Job Description: Hybrid in San Francisco
Position Overview:
The Senior Regulatory Affairs Specialist plays a vital role in ensuring compliance with global regulatory standards for medical devices. This role involves managing regulatory submissions, supporting audits, and fulfilling post-market obligations. The ideal candidate will possess strong regulatory expertise, with a focus on technical documentation and regulatory compliance. Collaboration across teams is essential to manage complaint reporting, support audits, and maintain compliance with EU MDR and other relevant regulatory frameworks.
Responsibilities and Capabilities:
- Oversee regulatory aspects of complaint handling, ensuring alignment with internal processes and external requirements.
- Assess and determine reportability of complaints and adverse events, ensuring timely submissions to regulatory authorities.
- Provide regulatory support during internal and external audits, collaborating with notified bodies and maintaining accurate documentation.
- Conduct product change assessments, clinical data reviews, and document evaluations for regulatory compliance.
- Maintain technical documentation to ensure adherence to EU MDR and other regulatory standards.
- Manage the creation, maintenance, and updates of technical files, ensuring ongoing compliance.
- Liaise with notified bodies and regulatory agencies (e.g., FDA, BSI) to maintain alignment with regulatory standards.
- Handle regulatory certification processes, including timely submission for renewals and new product approvals.
- Oversee regulatory fees and manage vendor contracts related to submissions and certifications.
Requirements:
- Bachelor’s degree in Science, Engineering, or related field.
- Strong understanding of ISO13485, ISO14971, FDA Complaint Management, reportability requirements, and EU Vigilance reporting.
- Experience in managing technical files, registrations, and certifications.
- Minimum of 5 years’ experience in regulatory affairs or quality assurance within the medical device industry.
- Strong project management skills with experience in technical documentation.
- Knowledge of EU MDR, FDA, and other global regulatory requirements.
- Excellent communication, leadership, and organizational skills.
- Proficient in MS Word, PowerPoint, Excel, and regulatory submission tools.
Additional Requirements:
- Adherence to all company policies and procedures.
- Ensure all activities comply with applicable legal and regulatory standards in relevant product lines and markets.
Company Culture and Benefits:
This position offers the opportunity to work with a collaborative, dedicated team committed to developing innovative products in the medical device field. The organization fosters a supportive environment focused on professional growth and excellence in compliance and quality standards.
