Unclassified - San Francisco, CA
posted about 2 months ago
Full-time - Mid Level
San Francisco, CA
About the position
The Senior Global Regulatory Affairs Specialist is a pivotal role focused on developing and implementing regulatory strategies for the submission, filing, and registration of medical devices in various surgical fields across global markets. This position involves providing strategic regulatory guidance, managing interactions with health authorities, and ensuring compliance with international standards such as FDA QSR and EU MDR.
Responsibilities
- Develop and implement regulatory strategies for clinical and non-significant risk medical devices, identifying risks and optimizing compliance with global standards.
- Prepare and submit international regulatory documents, including Technical Files and Design Dossiers for CE Marking, as well as FDA submissions (510(k), IDE, PMA).
- Oversee product registration submissions, ensuring alignment with business objectives and regulatory standards.
- Interact with regulatory agencies to expedite approvals and manage post-market surveillance, including adverse event reporting.
- Collaborate with clinical operations to align study results with regulatory requirements and ensure technical documentation supports product approvals.
- Serve as the regulatory representative on cross-functional teams, advising on product changes, labeling, and risk management.
- Maintain regulatory procedures, support product lifecycle management, and write regulatory justifications for design changes.
Requirements
- Bachelor's degree in engineering, life sciences, or a related discipline.
- 5+ years in Global Regulatory Affairs within medical devices or biotechnology, with expertise in general/plastic surgery, cardiology, or dermatology preferred.
- Experience with Notified Bodies, Competent Authorities, and clinical registration databases.
- Proficiency with EU MDR, FDA QSR, ISO 13485, and lifecycle management for high-risk devices.
- Strong project management and critical thinking skills, with proven ability to manage complex submissions.
- Excellent written and verbal communication skills and proficiency in Microsoft Office.
Nice-to-haves
- Experience in managing complex submissions in a fast-paced environment.
- Familiarity with global regulatory frameworks beyond the EU and US.
Benefits
- Health insurance coverage
- Flexible scheduling options
- Professional development opportunities
- Paid holidays
- 401k retirement savings plan
