Senior Regulatory Affairs Specialist (Hybrid)

$97,900 - $156,900/Yr

Stryker Employment Company - San Jose, CA

Full-time - Mid Level

Remote - San Jose, CA

About the position

The Senior Regulatory Affairs Specialist at Stryker plays a crucial role in ensuring the marketability of Surgical Support devices. This position involves supporting new product development, authoring regulatory submissions, and maintaining compliance with U.S. and global regulatory requirements. The specialist will work closely with cross-functional teams and regulatory agencies to facilitate product approvals and ensure adherence to regulations.

Responsibilities

• Support new product development and business development by authoring regulatory submissions and international registration deliverables.
• Update and review technical files and document design changes.
• Support manufacturing and quality projects, interacting with regulatory agencies and notified bodies.
• Act as the Regulatory Subject Matter Expert (SME) on cross-functional teams and a key point of contact for internal partners.
• Participate in product sustaining teams to ensure compliance with US, EU, and global regulatory requirements.
• Author and submit electronic regulatory submissions for the FDA and Notified Body.
• Prepare EU design dossiers/technical files and related product documentation.
• Assist in developing regulatory strategy, approval pathways, and compliance activities.
• Negotiate with regulatory authorities to ensure compliance and efficiency of reviews.
• Track the status of applications under regulatory review and provide updates to teams.
• Support international submissions and regulatory notifications.
• Perform regulatory reviews for technical documents such as clinical documents and post-market surveillance reports.
• Maintain current product registrations and assist in processing registration changes.
• Assist with the creation of regulatory procedures and updates to technical and QMS procedures.

Requirements

• Bachelor's Degree in Engineering, Science, or related degree.
• Minimum 2 years' experience in an FDA-regulated industry.
• Strong time management skills and ability to coordinate and execute regulatory items.

Nice-to-haves

• Master's Degree in Regulatory Affairs or RAC certification preferred.
• 1-2 years of regulatory affairs experience within the medical device industry.
• Knowledge of FDA and international medical device regulations and standards (e.g. EU MDR) preferred.

Benefits

• Salary range of $97,900.00 - $156,900.00 plus bonus eligible and benefits.