Staff Specialist, Regulatory Operations (R450570)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Supports new product development and product lifecycle Regulatory activities to enable and maintain global market access. Acts as a liaison between the division and in country regulatory representatives. Acts as a catalyst for globalization. Aids in the support of Corporate initiatives for the advancement of global activities at the Division. Viewed as departmental resource.
- Works under general supervision and instruction of more experienced staff.
- Reports observations/ problems clearly and concisely and takes appropriate actions.
- Demonstrates developing of advanced technical leadership skills within the department.
- Possesses and applies a broad knowledge and understanding of worldwide regulatory and legal frameworks, worldwide regulatory requirements, legislation, processes and procedures.
- Demonstrates strong project management, writing, coordination, and execution of regulatory items, with emphasis on regulatory submissions and maintenance activities.
- Plans, conducts and executes assignments, reviewing progress and evaluating results.
- Recommends changes in procedures when indicated including ways to incorporate global requirements.
- Operates with appreciable latitude for independent action or decision, and reviews progress with management.
- May direct work of Specialist or Sr. Specialist.
- Acts as a point of contact for Regulatory teams in global distribution networks.
- Supports the New Product Submission Planning process for worldwide product registrations.
- Contributes to the development of global regulatory strategies, providing regulatory input to new product development and product lifecycle planning.
- May contribute to regulatory impact assessment of proposed changes to launched products and the impact on global registrations.
- Support the development and maintenance of international and product technical files.
- May review collateral material as needed.
- Provide global strategy guidance and/or training to other functional teams.
- Monitor emerging global issues and identify solutions.
What You Need
- B.S. or B.A. Degree required.
- RAC certification preferred.
Qualifications & Experience
- 5 or more years of relevant experience required.
- Basic to intermediate understanding of quality system regulations, medical device legislation and other regulations related to global market access preferred.
- Candidates with multilingual communication skills preferred
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