Role OverviewWe are looking for a Regulatory Affairs Leader to join our team with the Aortic Business Group. In this role, you will plan, develop, and prepare regulatory strategies and coordinate regulatory planning aimed at achieving and maintaining global marketing approvals or clearances for new, modified, and existing products.
What You Will Do
Provide direction for regulatory team members for both pre- and post-market product strategies, comprehensive submission planning, regulatory agency discussions, and approval timelines.
Why It Might Be a Fit
You will provide management and leadership for Regulatory Associate’s goals, objectives, projects and responsibilities, and lead and manage activities that create and improve the Regulatory function and Gore Medical by facilitating accurate, timely, and consistent regulatory compliance, submissions, and regulatory processes.
Requirements
- Bachelor’s degree
- At least 8 years of experience in medical device Regulatory Affairs
- Extensive knowledge of FDA and international regulations related to Class III implantable medical devices
- Hands-on experience with PMA products
- Proven track record in managing complex global regulatory strategies
- Experience actively working with cross-functional teams to influence the direction and meet timelines
- Ability to prioritize work and adapt to shifting priorities
- Demonstrated communication and organizational skills
Benefits
- Remote work arrangement
- Eligibility dependent on the responsibilities of the role and business needs
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