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Senior Regulatory Affairs Leader
2 months ago
Join a Leading Organization
We are proud to be recognized as one of the World's Best Workplaces by Fortune Magazine, offering 12 paid holidays annually.
About the Role
We are currently looking for a Senior Regulatory Affairs Leader to join our Instruments division, with the flexibility to work remotely across the United States.
Who We Seek
We value strategic thinkers who enjoy analyzing data and trends for effective planning and forecasting. Our ideal candidates are goal-oriented orchestrators who can effectively coordinate skilled teams towards achieving significant objectives. Additionally, we appreciate business-oriented evaluators who can interpret information to illustrate the impact of business initiatives and regulatory trends.
Your Responsibilities
As the Senior Regulatory Affairs Leader, you will play a crucial role in supporting new product development for both domestic and international markets. Your contributions will include:
- Developing and updating regulatory strategies in response to regulatory changes.
- Ensuring compliance by conducting thorough assessments and submissions for product clearances and approvals.
- Analyzing the interplay between global trends, stakeholder concerns, and regulatory requirements.
- Participating in advanced advocacy activities.
- Aligning regulatory strategies with organizational goals.
- Providing guidance on integrating regulatory considerations into product strategies.
- Identifying regulatory pathways for initial product designs and offering insights to internal stakeholders.
- Assessing market access requirements and developing solutions to overcome potential obstacles.
- Negotiating with regulatory authorities on complex issues throughout the product lifecycle.
- Managing the development and execution of new regulatory procedures.
- Training stakeholders on current and new regulatory requirements to ensure compliance.
What You Need
A Bachelor's degree is required, preferably in Engineering, Science, or a related field. An advanced degree in Regulatory Science is preferred. You should have:
- 9+ years of experience in an FDA-regulated industry, preferably with medical devices.
- 7+ years of experience in Medical Device Regulatory Affairs.
- Experience drafting regulatory submissions to the FDA.
- Strong understanding of Quality System Regulations and Medical Device Directives.
- Advanced proficiency in Microsoft Office Suite.
Compensation and Benefits
The salary range for this position is $112,000 to $239,900, plus eligibility for bonuses and benefits. Individual compensation may vary based on skills, experience, and other relevant factors.
Health Benefits Include:
Medical and prescription drug insurance, dental and vision insurance, critical illness insurance, and personalized healthcare support.
Financial Benefits Include:
Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, and Employee Stock Purchase Plan (ESPP).
About Stryker
Stryker is dedicated to providing innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine, impacting over 150 million patients annually.
Equal Opportunity Employer
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.
