Director of Regulatory Affairs
Regulatory Affairs Senior Specialist - Spinal Medical Devices
Are you ready to embark on an incredible journey with an industry leading spinal medical device company? If you're passionate about regulatory affairs, excited about the spinal implant and instrument industry, and ready to experience a new chapter in life, then this opportunity is tailor-made for you!
Why San Diego?
San Diego isn't just a city; it's a lifestyle upgrade. Imagine waking up to endless sunshine, pristine beaches, and a city buzzing with culture and adventure. San Diego offers not just a career but a chance to live your best life. Say goodbye to the winter blues and hello to a world of possibilities in beautiful San Diego!
Key Responsibilities
As a Regulatory Affairs Senior Specialist your role will include:
- Lead Regulatory Strategy: Shape regulatory strategies for US Class II implants and instruments.
- FDA Expertise: Lead 510(k) premarket notifications for US FDA.
- Global Impact: Prepare regulatory submissions for Australia (STEDs, EPCs, DoCs).
- Process Excellence: Improve processes, evaluate data/metrics, maintain databases, and ensure information accessibility.
Requirements
To thrive in this role, you should have:
- Education: A Bachelor's degree in engineering or life sciences.
- Experience: Minimum of five years in the medical device industry.
- Regulatory Knowledge: Strong understanding of FDA Quality System Requirements (QSR) and ISO 13485.
- Submission Expertise: Experience with 510(k) submissions.