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Regulatory Affairs Specialist II Jobs

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
Irb Regulatory Coordinator Ii
By Fred Hutch At Seattle, WA, United States
Excellent time management skills and meet deadlines
Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System.
Previous experience working with online/web-based platforms for clinical trial management systems
Manage the regulatory tracking and archive systems (e.g. SharePoint, Clinical Trials Management System, shared network drive, etc.).
A minimum two years of regulatory, human research protection or related experience in a research environment.
Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols.
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 Cmc
By Viatris At United States
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.
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.
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.
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 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.
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 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 Associate Ii - Alliance Management (Remote)
By Tolmar Inc. At , Fort Collins, 80526 $75,000 - $85,000 a year
Knowledge of Database Management software.
Prepare and coordinate eCTD documentation for new marketing authorizations and lifecycle management submissions for RoW and Canada.
Assist Regulatory Management and other Regulatory Associates, as requested.
Maintain electronic document management system, as required, for responsible products.
The Regulatory Associate II, Alliance Management is expected to operate within the framework of Tolmar’s Core Values:
Working conditions are consistent with a normal office environment and/or remotely from home office.
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 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
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.
Regulatory Coordinator Ii Jobs
By Fred Hutch At Seattle, WA, United States
Strong organizational and document management skills.
Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team.
Bachelor’s Degree in a health related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent experience required.
A minimum of 3 years relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination function required.
Experience using central and local IRBs.
Ability to interpret and apply local, state, and federal requirements.

Are you looking for an exciting opportunity to use your regulatory expertise to make a difference? We are looking for a Regulatory Affairs Specialist II to join our team and help us ensure compliance with all applicable regulations. You will be responsible for developing and maintaining regulatory strategies, preparing regulatory submissions, and providing regulatory guidance to internal stakeholders. If you are an experienced regulatory professional with a passion for making a positive impact, this could be the perfect job for you!

A Regulatory Affairs Specialist II is responsible for ensuring that a company’s products comply with all applicable laws, regulations, and standards. This includes researching and interpreting regulations, preparing and submitting regulatory documents, and providing guidance on regulatory compliance.

What is Regulatory Affairs Specialist II Skills Required?

• Knowledge of applicable laws, regulations, and standards
• Excellent research and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Attention to detail
• Project management skills

What is Regulatory Affairs Specialist II Qualifications?

• Bachelor’s degree in a related field
• At least two years of experience in regulatory affairs
• Certification in regulatory affairs (preferred)

What is Regulatory Affairs Specialist II Knowledge?

• Knowledge of applicable laws, regulations, and standards
• Knowledge of regulatory requirements for product development and approval
• Knowledge of Good Manufacturing Practices (GMPs)
• Knowledge of medical device regulations

What is Regulatory Affairs Specialist II Experience?

• Experience in regulatory affairs
• Experience in medical device or pharmaceutical industry
• Experience in preparing and submitting regulatory documents

What is Regulatory Affairs Specialist II Responsibilities?

• Research and interpret applicable laws, regulations, and standards
• Prepare and submit regulatory documents
• Provide guidance on regulatory compliance
• Monitor regulatory changes and update internal procedures