Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. This role is based San Francisco Bay Area, offering a unique chance to make a significant impact in the medical device industry.
Key Responsibilities:
- Lead regulatory strategy and submissions for Class 2 & 3 products, including PMA and 510(k) applications.
- Develop and execute regulatory plans, ensuring compliance with FDA requirements.
- Collaborate with cross-functional teams to drive product development and regulatory approval processes.
- Stay abreast of regulatory changes and industry trends to guide strategic decision-making.
Qualifications:
- Proven experience with PMA and 510(k) submissions within the spine or related medical device sectors.
- Strong understanding of FDA regulatory requirements and industry standards.
- Excellent communication and leadership skills, with a track record of successful project management.
- Ability to thrive in a fast-paced, innovative environment.
This role offers the opportunity to work with a forward-thinking company working closely with the senior leadership of the Regulatory team. If you are passionate about regulatory affairs and eager to contribute to cutting-edge advancements, we would love to hear from you.
We look forward to connecting!
