Register
Recruit Create CV

Senior Regulatory Affairs Specialist Jobs in Des Moines, Iowa

Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Des Plaines $71,300 - $142,700 a year
Interpret and apply regulatory requirements
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Principles and requirements of promotion, advertising and labeling
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Regulatory Affairs Intelligence Specialist
By Abbott Laboratories At , Plymouth $56,700 - $113,300 a year
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Experience in program management a plus
Experience with document management systems a plus
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned
Strong verbal and written communication skills · Strong attention to detail and organizational skills
Regulatory Affairs Specialist Jobs
By Philips At , Cambridge
Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations.
Experience with Software Medical Devices strongly preferred.
Proficient computer skills in Microsoft Office Suite
Read more about our employee benefits.
Regulatory Affairs Specialist Cmc
By Viatris At , Remote $41,000 - $93,000 a year
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Regulatory Affairs Specialist Ii
By Thermo Fisher Scientific At , Fremont, 94555, Ca
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Perform other related duties and responsibilities, on occasion, as assigned.
Excellent communication skills and attention to detail.
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
Must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Excellent oral presentation skills.
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
Senior Regulatory Affairs Associate, Fsp
By Parexel At , Remote
Management Strong management with depth of experience working for global health authorities.
Experience with project lifecycle and management
Strong management with depth of experience working for global health authorities.
Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.
Interacts professionally at multiple levels including senior management within a client organization.
Successfully penetrates executive management levels or other business units within a client organization.
Regulatory Affairs Specialist - Remote
By Corza Medical At , Remote
Superior Quality & Service. We deliver extraordinary experiences.
Development of tracking documents and follow-up to assure submissions are managed appropriately.
Minimum 2 years of experience in Regulatory Affairs in the medical device/drug industry.
Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America.
Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred.
We do what is right.
Regulatory Affairs Specialist Jobs
By GC America Inc At , Remote
Consult with Product Management and Sales Administration on regulatory requirements for US and Canada
Work with product management to prepare, compile and maintain post market documentation
3 years of experience in regulatory affairs or quality assurance
Monitor regulatory environment in assigned markets(US, Canada) and communicate to global and domestic stakeholders
Prepare responses to regulatory authority requests by working with GCC regulatory affairs
Work with other GC Companies regulatory associates to support GCA sales and marketing needs associated with regulatory documentation
Specialist Data Maintenance Regulatory Affairs
By Viatris At , Remote $41,000 - $93,000 a year
Builds knowledge of electronic and paper publishing systems and tools and applies these tools to produce CMC change management outputs.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Quality Specialist - Rn (Regulatory Affairs)
By Stanford Health Care At , Palo Alto, 94304, Ca $64.52 - $85.49 an hour
Attends ongoing education as required for clinical database management.
Three (3) years of progressively responsible and directly related work experience
SHC Commitment to Providing an Exceptional Patient & Family Experience
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
Conducts comprehensive quality and patient safety studies, assessments, and evaluations of specific clinical activities for effectiveness
Conducts work independently and escalates system issues as necessary.
Senior Regulatory Specialist Jobs
By Compliance Group Inc At Greater Columbus Area, United States
Applies regulatory and technical knowledge to a wide variety of complex work assignments.
Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
Knowledge of regulations and standards affecting IVDs and/or biologics
Responsible for implementing and maintaining the effectiveness of the quality system.
Supports manufacturing/operations day to day activities for change control.
Provides consultation/advice to regulatory specialist for change control and product development.
Regulatory Affairs Sr Specialist (Remote)
By Zimmer Biomet At , Remote $98,700 - $122,500 a year

Requisition Number AMER27218 Employment Type Full-time Location Virtual Office - Indiana Job Summary Zimmer Biomet is a global medical technology leader. Our team members are ...

Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
Senior Manager Regulatory Affairs | $90,000- 140,000/Yr
By PWR Staffing & Recruiting At New York, NY, United States
Ensure claims are compliant with The Avon and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products, including OTC
Product development experience is strongly preferred
Skin and personal care, including OTC claim review experience, strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global At New York, NY, United States
-knowledge and experience in the insurance sector
-prior experience as an insurance supervisor
-prior experience as an actuary, insurance contract lawyer, or consultant in the financial services
-prior experience in coordinating projects involving a wide array of stakeholders.
-prior experience on ESG or cyber matters.
-ability to navigate and understand prudential regulation and supervisory guidance applicable to the insurance sector
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121 $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Senior Regulatory Affairs Manager - Hybrid
By Hi-Quality Recruits At New York, NY, United States
Ensure claims are compliant with the company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers, including verbal presentations
Excellent organizational and analytical skills to complete assignments accurately
Senior Manager Regulatory Affairs
By Jasper Therapeutics At Redwood City, CA, United States
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Must be able to effectively identify data needs, and successfully present to management.
Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
Maintain up-to-date knowledge of current regulations for applicable territories. •
Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.
Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
Regulatory Affairs Specialist Jobs
By ICON At , Farmingdale, 11735
Experience in regulatory requirements in clinical phase of biologics drug development is a plus
Excellent written and oral communication skills
Strong technical writing and editing skills
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
Initiate regulatory submission when required and support ICON team with Regulatory Inspections
Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
Specialist, Regulatory Affairs Jobs
By Edwards Lifesciences At ,
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge of new product development systems
Ability to manage competing priorities in a fast paced environment
Regulatory Affairs Specialist Jobs
By Verathon At , Bothell $89,500 - $138,600 a year
Manage regulatory release authorization process
Experience working in an FDA regulated company for medical device or pharma is preferred
2+ years’ experience in quality assurance or regulatory affairs is preferred
Previous experience in a position that required multi-department interactions
Able to manage time effectively
Develop and compile documentation in support of new registrations
Regulatory Affairs Specialist Jobs
By Medtronic At , Woburn
Assist in keeping company informed of regulatory requirements in the International Regions.
Host meetings with relevant R&D, Quality, Manufacturing facility, Marketing and Cross Functional Teams as needed to support global registration requirements.
Bachelor's degree with 2 years of regulatory affairs experience
An advanced degree with 0 years of regulatory affairs experience
3+ years of medical device regulatory affairs experience
Experience with international submissions and experience with the FDA
Regulatory Affairs Specialist Jobs
By AM Logic Corporation At , Edison, 08820, Nj
Communicate submission requirements to product development and process improvement teams.
Develop detailed strategies and perform activities necessary to secure domestic and foreign regulatory clearance, approval, and registration of products.
Maintain annual facility registrations and product listings as appropriate.
Develop competitive regulatory strategies and execute on filing submissions to regulatory authorities and ensure the maintenance of regulatory files.
Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
Requires Bachelors in Pharmacy, Regulatory Affairs, any Scientific Degree, or related.
Regulatory Affairs Specialist-Cleveland Jobs
By Biolink360 At , Pittsburgh, Pa
Extensive project management skills with the ability to work under deadlines, handle multiple priorities simultaneously, and work across multi-disciplinary teams.
3-7 years of Regulatory Affairs experience in the medical device or other area of life science industry.
FDA regulatory submission experience (Pre-Submission, 510Ks, De Novo, IDEs) and international submission experience a plus.
Do want the flexibility to work from home, with only being in the office 1-2 days/week?
Devise and execute with regulatory pathways and strategies, premarket FDA, and international regulatory submissions.
Serve as point person for external audits by regulatory and third party auditors.
Regulatory Affairs Specialist Jobs
By Medtronic At , Minneapolis, 55432, Mn
Strong organization and time management skills
Bachelor’s Degree with 2 years of regulatory affairs experience
An advanced degree with 0 years of regulatory affairs experience
2+ years of medical device regulatory affairs experience
Ability to effectively manage multiple projects and priorities
Excellent written and verbal communications skills
Regulatory Affairs Specialist 3 - Remote
By The Cooper Companies At , Trumbull, Ct $92,847 - $125,000 a year
Other Skills and Abilities: Knowledge and understanding of US, EU MDR and international medical device regulations.
Certificates, Licenses, Registrations: RAC certification is preferred.
Regulatory Experience: Minimum 4 years (Required).
510(k)/Technical File Experience: Minimum 4 years (Required).
Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.
Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions.
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121, Ca $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Global Regulatory Affairs Specialist
By ICON At , , Ga
An ambitious regulatory professional with experience of working as Regulatory Specialist across multiple regions. Additional requirements include:
Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
Become part of the supportive and extremely knowledgeable regulatory professional team who are collaborative.
Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
What we can offer you:
Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages.