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Global Regulatory Affairs Specialist Jobs

Global Regulatory Specialist Jobs
By eBay At Draper, UT, United States
2-5 Years Proven Project Management Experience.2-5 years experience with a federal government agency is preferred.
Effective and confirmed negotiation skills and have the ability to influence decisions and others.
Handle and support critical issues from regulators and monitoring authorities, media, and non-government organizations from around the world.
Support managing and further developing the eBay Regulatory Portal.
Be proficient with eBay’s customer service tools.
Conduct investigations and analysis of non-compliant/potentially criminal conduct.
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
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.
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
Global Clinical & Regulatory Affairs Operations Coordinator
By Orion At , $28 an hour
Experience with vendor and supplier management and engagement
Experience with contract management systems for legal agreements and contracts
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.
Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations
A minimum of 3 years' experience in clinical regulatory affairs highly preferred.
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 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
Global Customer Experience Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At , Westborough, Ma $106,692 - $149,366 a year
Experience and knowledge of all call center KPI & SL metrics.
Experience in driving change via business cases for transformation.
BA/BS in Business, communications. Equivalent years of experience in the business operation field and or medical device.
Experience of managing a critical path regarding customer complaints would be advantageous
Hands-on experience with service and support workflow tools such as ServiceNow, SFDC, Veeva, Oracle Zendesk.
Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.
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.