Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All 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. Stryker is an EO employer – M/F/Veteran/Disability.
The Principal Regulatory Affairs Specialist develops and implements strategies for worldwide governmental approvals to introduce new and modified products to market, advises on regulatory requirements, prepares and/or supports worldwide regulatory submissions, and negotiates their approval. This role may work on highly complex submissions and have input to higher-level regulatory strategy decisions.
- Prepare and/or support worldwide submissions for new products and product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager/VP as necessary and negotiate submission issues directly with agency personnel.
- Work integrally with new product development and clinical research teams to provide support, guidance and planning to secure approvals for clinical investigations. Plan, coordinate and prepare document packages for regulatory submissions, including Class II and III U.S. FDA Pre-Market Approval (PMA), Pre-Market Notification (510(k)), Investigational Device Exemption (IDE), Design Dossiers, Shonins, Canadian Device License Applications, and internal “Letters to File.”
- Support ongoing regulatory compliance activities to include regulatory assessment of product design or process change, preparation of annual reports, required PMA supplements, establishment license, and device listing renewals.
- Negotiate directly with the FDA and other worldwide agencies on applicable products/projects.
- Develop and implement global regulatory strategies for new and modified products.
- Maintain submission correspondence files and other regulatory files in a complete and secure manner.
- Create project deliverables, aligned with appropriate internal and external guidance documents.
- Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign-off on product, supplier, and manufacturing changes for compliance with applicable regulations. Support highly technical or major business segment products lines, special projects or strategic initiatives.
- Provide regulatory input in quality system assessments.
- Research new FDA and worldwide regulatory decisions or rulings and how they may affect the company's activities.
- Conduct corporate training in GMP and other regulations.
- Support various internal compliance audits.
- May have responsibilities directing daily activities of and mentoring less-senior members of Regulatory Affairs team.
- Track and report worldwide registration status.
- Implement process improvement projects within Regulatory Affairs.
- Perform other related duties as assigned.