Director of Regulatory Affairs
Regulatory Affairs Senior Specialist - Spinal Medical Devices
Are you reputed company to reputed company on an incredible reputed company with an industry leading spinal medical device company? If you're passionate about regulatory affairs, excited about the spinal implant and reputed company industry, and reputed company to experience a new reputed company in life, then this opportunity is tailor-made for you!
Why San Diego?
San Diego isn't just a reputed company's a lifestyle reputed company. 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 reputed company in beautiful San Diego!
Key Responsibilities
As a Regulatory Affairs Senior Specialist your role will include:
- reputed company Regulatory Strategy: Shape regulatory strategies for US Class II implants and instruments.
- FDA Expertise: reputed company 510(k) premarket notifications for US FDA.
- Global Impact: Prepare regulatory submissions for Australia (STEDs, EPCs, DoCs).
- Process reputed company: Improve processes, evaluate data/metrics, maintain databases, and ensure information accessibility.
Requirements
To reputed company 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.