Regulatory Affairs Manager - Permanent - Remote
Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. This is a permanent role based remotely out of the San Francisco Bay Area.
Primary Responsibilities :
In this role, you will provide direct support to company operations for their globally distributed products. This role is a global regulatory position, working closely with site Quality, R&D, Operations, and regional RA peers to support global licensing and registrations, and to ensure the effective execution and management of changes.
Skills & Requirements :
- Bachelor's degree in a scientific discipline is required. Advanced degree is preferred.
- 10+ years of experience in medical device industry. 5+ years of experience in Electrical / Active medical device industry.
- 5+ working knowledge of appropriate global medical device regulations, requirements, and standards.
- 2+ years of people management : direct & indirect.
- Should have experience of independently authoring complete 510k submissions, Health Canada Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
- Experience in participating in national or international standards activities.
- Must be eligible to work in the US.
The Manager, Regulatory Affairs will :
- Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio.
- Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
- Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or [email protected] .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Future Opportunities - Join Our Talent Pipeline for Manager/Sr. Manager, Global Regulatory Affairs
Global Regulatory Affairs Strategy roles (U. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Assist Re...
Manager, CMC Regulatory Affairs
Manager, CMC Regulatory Affairs . Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross‐functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the ...
Regulatory Affairs Project Manager
Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Acts as a regulatory representative on core product developme...
Manager, Regulatory Affairs
Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross‐functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity comp...
CMC Regulatory Affairs Manager
Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. An in-depth knowledge of ICH and regional CMC regulatory requiremen...
Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Regulatory Affairs Manager – APAC. Regulatory Affairs Manager – APAC. You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide ...
Associate Regulatory Affairs Manager
The Associate Regulatory Affairs Manager will be responsible for completing the regulatory work for the Health and Biosciences business and applicable joint ventures, with a focus on food applications, for the U. Associate Regulatory Affairs Manager. Update Registration List to communicate the statu...
Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Regulatory Affairs Manager – APAC. Regulatory Affairs Manager – APAC. You will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide ...
Regulatory Affairs Manager - Pharma
Experience in representing regulatory affairs on development project teams. Background in Clinical regulatory affairs: Clinical study reports, protocols, Investigator Brochure, investigator updates, ICF, IRB, site initiation, sponsor/investigator responsibilities etc. Regulatory Affairs Certificatio...
Manager, Global Regulatory Affairs, HI-Bio
Biogen company, is seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). Combination of the following can be considered: PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS ...