Senior Specialist, Regulatory Operations (R451554)
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
Develop and apply intermediate knowledge and understanding of regulatory requirements, legislation, processes and procedures to support new product development and product lifecycle activities. Act as a liaison between the division and in country regulatory representatives to enable and maintain global market access. Acts as a catalyst for globalization. Viewed as departmental resource.
Key Areas of Responsibility:
- Works under general supervision and instruction of more experienced staff.
- Reports observations/ problems clearly and concisely and takes appropriate actions.
- Develops and applies intermediate technical leadership skills to plan and implement activities in support of global regulatory strategy, submissions and renewals
- Assesses regulatory intelligence to develop intermediate regulatory knowledge and contribute to the development of global regulatory strategies, providing regulatory input to new product development and product lifecycle planning
- Demonstrates developing project management, regulatory writing, coordination, and execution skills, 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.
- Acts as a point of contact for Regulatory teams in global distribution networks.
- Supports the New Product Submission Planning process for worldwide product registrations.
- May contribute to regulatory change assessments and activities to support global registration impacts.
- Plans, collects and organizes information to support creation and maintenance of international and product technical files and submissions.
- Provides input and assists in the identification of solutions to address changes in global regulatory legislation and landscape.
- May review collateral material as needed.
Education / Work Experience:
- B.S. or B.A. Degree required.
- RAC certification preferred
- Typically a minimum of 3 years experience
Knowledge / Competencies:
- 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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