Director of Regulatory Affairs

Looking for a straightforward job? We're hiring a Director Of Regulatory Affairs! Based in Remote, this position puts you in a prime location for professional and personal growth. This position requires a strong and diverse skillset in relevant areas to drive success. In recognition of your expertise, this position offers a salary of a competitive salary.

 

 

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.

 

Ready to Apply?

If you are a motivated individual ready to contribute to a thriving team, we encourage you to apply now! We are excited to review your application.