Current jobs related to Senior Regulatory Affairs Specialist - South San Francisco, California - R&D Partners
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...
-
Senior Director Regulatory Affairs
2 weeks ago
South San Francisco, California, United States Structure Therapeutics Full timeJob Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a seasoned Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our products. As a key member of our leadership team, you will be responsible for guiding our products through development, approval, and post-approval...
-
Regulatory Affairs Specialist
2 weeks ago
San Mateo, California, United States Collabera Full timeJob Title: Regulatory Affairs SpecialistCollabera is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Perform data entry and maintenance of...
-
Senior Regulatory Affairs Specialist
1 month ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeJob SummaryRegulatory Affairs Specialist - CMCThis position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. The successful candidate will serve as the Regulatory Affairs (RA) CMC project representative to the CMC sub-team and the RA team, and will serve as an ad hoc member...
-
Senior Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States BD (Becton, Dickinson and Company) Full timeJob Description SummaryAs a Senior Specialist in Regulatory Affairs, you will play a critical role in supporting the development, sustainment, and end-of-life activities of Medical Devices and Non-Medical Devices, as well as associated Software and Accessories, on a global basis from a Regulatory Affairs standpoint.About the RoleThis fully remote position...
-
Senior Director, Regulatory Affairs Lead
1 week ago
South San Francisco, California, United States Structure Therapeutics Full timeJob Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our biotechnology products. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory...
-
Senior Regulatory Affairs Specialist
1 month ago
San Diego, California, United States BioTalent Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at BioTalent. This is a hybrid on-site role that requires at least 5-7+ years of hands-on Regulatory experience, including 510(k) authorship.Key Responsibilities:Document Coordination: Coordinate submission and review of documents for...
-
Regulatory Affairs Specialist
6 days ago
San Francisco, California, United States Yoh Full timeRegulatory Affairs SpecialistYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements. The position offers a hybrid schedule and the opportunity to work with a growing...
-
Senior Regulatory Affairs Specialist
4 weeks ago
South San Francisco, California, United States insitro Full timeAbout the RoleAt insitro, we're revolutionizing the way we approach drug discovery and development using machine learning and data at scale. We're seeking a highly skilled and experienced Regulatory Affairs professional to join our team as a Global Regulatory Lead. In this role, you'll be responsible for developing and implementing global regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of...
-
Senior Director of Regulatory Affairs
1 week ago
San Francisco, California, United States KMR Search Group Full timeJob Title: Senior Director, Regulatory AffairsJob Description Job Summary:This role will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The Senior Director, Regulatory Affairs will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for...
-
Regulatory Affairs Specialist
3 days ago
San Mateo, California, United States RICEFW Technologies Full timeJob Title: CMC Regulatory Affairs Data Entry SpecialistFoster City, CAJob Summary:RICEFW Technologies is seeking a highly skilled CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA...
-
Regulatory Affairs Specialist
1 week ago
South San Francisco, California, United States AbbVie Full timeJob Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies to ensure...
-
Regulatory Affairs Specialist
3 weeks ago
San Francisco, California, United States Yoh Full timeRegulatory Affairs Specialist Job DescriptionYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.Key Responsibilities:Plan...
-
Senior Director Regulatory Affairs
2 weeks ago
San Francisco, California, United States KMR Search Group Full timeJob Title: Senior Director, Regulatory AffairsJob DescriptionJob Summary:This position will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The successful candidate will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for preparation...
-
Regulatory Affairs Specialist
2 weeks ago
South San Francisco, California, United States AbbVie Full timeJob Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to our global development teams.Key Responsibilities:Develop and implement regulatory strategies for assigned products or...
-
Regulatory Affairs Director
3 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob DescriptionJob SummaryAbdera Therapeutics Inc. is a precision oncology company developing innovative targeted radiation therapies. We are seeking a highly experienced Regulatory Affairs professional to join our team as a Director/Senior Director Regulatory. The successful candidate will be responsible for developing and implementing regulatory strategies...
-
Regulatory Affairs Director
6 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeAbout the RoleAbdera Therapeutics is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies and contingencies for assigned programs, in order to support Abdera's development objectives.Key ResponsibilitiesLead and prepare FDA...
-
Regulatory Affairs Director
4 weeks ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...
-
Regulatory Affairs Director
4 weeks ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...
Senior Regulatory Affairs Specialist
2 months ago
R&D Partners is looking for a Senior Regulatory Affairs Specialist III.
Key Responsibilities:
- Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.
- Draft and maintain submissions and product technical files, ensuring adherence to Global Regulatory directives and regulations.
- Oversee submission processes for various device regulatory approvals, including IVDR/CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
- Analyze and communicate product-specific regulatory issues that could significantly affect business units, the corporation, or customers.
- Engage with regulatory authorities on relevant regulatory and technical issues as necessary.
Qualifications:
- Bachelor's Degree (B.S./B.A.) in a scientific, engineering, or related technical discipline; advanced degree is preferred.
- Regulatory Affairs Certification is a plus.
- A minimum of 5 years of experience in regulatory affairs within IVD or medical devices, with a preference for IVD device experience.
- Proficiency in Microsoft applications and a solid understanding of PC functionalities are essential.
- Experience with regulatory submissions, including IVDR CE submissions, IDE, 510(k), and PMA submissions, is highly desirable.
Why Join R&D Partners?
As a valued employee, you will enjoy a comprehensive benefits package that includes:
- Medical insurance options – PPO, HMO & HSA
- Dental and Vision insurance
- 401k retirement plan
- Employee Assistance Program
- Long-term disability coverage
- Weekly payroll
- Expense reimbursement
- Online timecard approval system
Compensation:
- Salary range: $117,998 – $156,000 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research, and engineering roles. We offer job opportunities within leading pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
R&D Partners is an equal-opportunity employer.
