Staff Regulatory Affairs Specialist (Remote)

Stryker • Fremont, CA

5d • $77,700 - $207,400 • Remote

About The Position

We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States. As the Staff Regulatory Affairs Specialist, you will support Stryker’s neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, and interact with regulatory agencies/notified bodies in major markets including the US, EU, Canada, Japan, China, Australia, Brazil, and more.

Requirements

• Bachelor’s Degree (B.S. or B.A.)
• Minimum 4 years of experience in an FDA-regulated industry
• Minimum 2 years of experience in regulatory affairs
• Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)

Nice To Haves

• Bachelor's degree in engineering, science, or related field
• Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
• Experience with Class II or Class III medical devices
• Experience authoring 510(k) submissions or equivalent regulatory filings
• Experience interacting with regulatory agencies or supporting regulatory meetings

Responsibilities

• Develop and execute regulatory strategies for pre-market products to achieve market access across global regions.
• Evaluate regulatory requirements and identify submission pathways for new products, ensuring alignment with applicable regulations.
• Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals.
• Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
• Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
• Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
• Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
• Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.

Benefits

• Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior