Stryker Corporation is hiring a Staff Regulatory Affairs Specialist, Pharmaceuticals (Remote)

Stryker Corporation is looking for a Staff Regulatory Affairs Specialist to support fluorescence imaging drug products for the Endoscopy Division’s Pre-Market Regulatory team. You will be responsible for preparing complex pharmaceutical submissions to regulatory bodies like the FDA and Health Canada, assessing post-approval changes, advising on regulatory pathways, and supporting health authority communications.

What You'll Do

• Support regulatory submission strategies and update them as needed through investigation of regulatory history, classification, and standards.
• Assess the acceptability of quality, nonclinical, and clinical documentation for submission filings to comply with regulatory requirements.
• Prepare submissions and supporting documents (e.g., CTD summaries) for approvals, such as CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations, and Letters to File.
• Ensure quality, nonclinical, and clinical data align with regulatory strategy and requirements to support proposed product claims.
• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding meetings, pathways, and submission follow-up.
• Advise personnel on regulatory requirements for quality, nonclinical, and clinical data for clinical study and marketing applications.
• Contribute to evaluations of the regulatory environment and provide input to the product lifecycle to ensure compliance.
• Demonstrate strong project management, writing, coordination, and execution of technical and scientific regulatory activities.
• Apply broad and advanced knowledge of regulatory and legal frameworks, requirements, legislation, processes, and procedures.

What We're Looking For

• Bachelor’s Degree
• 4+ years of experience in an FDA regulated industry
• 2+ years of pre- and/or post-market Regulatory Affairs experience
• Experience preparing submissions and supporting documents to gain approvals for clinical investigations and/or commercial distribution
• Ability to comply with constantly changing regulatory and clinical environments and prioritize work effectively
• Ability to understand and explain detailed regulatory compliance programs and issues
• Adaptable to a fast-paced environment with changing circumstances, direction, and strategy

Nice to Have

• Bachelor's Degree in Health Science or equivalent focus
• RAC certification or Advanced Degree (Masters in Regulatory Affairs)
• 4+ years of regulatory affairs experience within pharmaceuticals

Team & Environment

You will be part of the Pre-Market Regulatory team within the Endoscopy Division.

Benefits & Compensation

• Salary range of $95,700 - $207,400
• Bonus eligible
• Comprehensive benefits package

Work Mode

This is a remote position. Candidates can be located anywhere within the United States, with a listed location in San Jose, CA.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.