A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products.
Key Responsibilities : Participate in product development teams to provide regulatory supportCompile technical documentation for global regulatory submissions and registrationsReview QMS and product changes for compliance with regulatory requirementsRequired Qualifications : Bachelor's Degree in STEM, Medicine, or Life Science1-2 years of experience in medical device product development or related fieldsFamiliarity with medical device regulations in the US and / or EUKnowledge of relevant standards and guidance documents (e.
g., 21 CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required
Specialist III, Regulatory Affairs
Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
Specialist III, Regulatory Affairs
Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and...
Regulatory Affairs Specialist
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. ...
Principal Regulatory Affairs Specialist-Ultrasound
The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies and post market changes for complex, new/existing Ultrasound systems/devices. Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and o...
Regulatory Affairs Specialist
Regulatory Affairs is a team of more than 40 professionals located either at San Diego HQ or remotely around the globe. You will participate in the development of regulatory strategies and help prepare regulatory submissions:US submissions include (k)s, IDEs, and Q-SubsHealth Canada amendmentsEU sub...
Staff Regulatory Affairs Specialist, Infusion - Remote
Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance. Minimum 5 years of strong Regulatory Affairs experience in the medical device industry. Proven prior experience required owning and managing the end-to-end process ...
Senior Specialist, Regulatory Affairs, Critical Care
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Staff Regulatory Affairs Specialist - Hybrid
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
Regulatory Affairs Specialist 3.
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...