Senior Director, Regulatory Affairs

The Role:

We are seeking an experienced and highly skilled Senior Director of Regulatory Affairs  The Senior Director will provide hands-on direction and oversight for regulatory submissions, approvals, and post-market activities while collaborating with cross-functional teams to ensure the regulatory pathway supports product development timelines and market access.

A Few Key Responsibilities:

• Lead the development and execution of regulatory strategies for Class III medical devices to ensure timely approvals in global markets, including the U.S., EU, and other regions.
• Oversee the preparation and submission of regulatory documents to regulatory agencies (e.g., FDA, EMA) for product approvals, 510(k), PMA, and CE mark submissions.
• Lead regulatory affairs activities for clinical trials, ensuring alignment with regulatory requirements and submission timelines.
• Provide leadership in the development of regulatory strategies for product lifecycle management, including post-market surveillance, labeling updates, and adverse event reporting.
• Serve as the primary regulatory liaison with regulatory agencies, providing expert guidance and representing the company in meetings, negotiations, and inspections.
• Monitor and interpret changes in regulations and standards and provide guidance to the product development teams to ensure compliance.
• Drive continuous improvement in regulatory affairs processes, tools, and systems to enhance efficiency and compliance.
• Mentor and manage a team of regulatory affairs professionals, providing leadership, training, and development opportunities.

What you Bring:

• Bachelor's degree in a relevant field (e.g., life sciences, engineering); advanced degree (e.g., MS, MBA, or regulatory certification) preferred.
• 15 years of regulatory affairs experience within the medical device industry, with at least 5 years in a leadership role.
• Deep knowledge of regulatory requirements for Class III medical devices, including FDA regulations (21 CFR Part 820, 21 CFR 812, 21 CFR 820), ISO standards, and CE marking requirements.
• Proven track record of successful regulatory submissions (e.g., 510(k), PMA, IDE) and interactions with regulatory authorities.
• Experience with regulatory strategy and product development for complex, high-risk medical devices.
• Strong leadership and people management skills, with the ability to influence and collaborate with cross-functional teams.
• Excellent communication, presentation, and negotiation skills.
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.

Preferred Skills:

• Regulatory affairs certification (e.g., RAC) is highly desirable.
• Experience with emerging markets and global regulatory requirements is a plus.

Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, Ca is $190,000 and $225,000  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Salary : $190,000 - $225,000