Regulatory Affairs Leader
RemoteUnited States
Job Summary
Provide direction for regulatory team members regarding pre- and post-market product strategies, comprehensive submission planning, and regulatory agency discussions. Lead and manage Regulatory Associates' goals, objectives, and projects while facilitating accurate, timely, and consistent regulatory compliance for Gore Medical. Partner with cross-functional teams to ensure open communication and meet business and regulatory goals. Share regulatory knowledge to assist associates in developing expertise on labeling, promotional advertising, and compliance areas. Ensure communication of changing global regulatory requirements within the function and with other teams. This role supports the Aortic Business Group with a focus on global marketing approvals for new, modified, and existing products.
Required Qualifications
- Bachelor's degree
- 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
- Willingness to share experience and coach Regulatory Associates in order to successfully execute on regulatory assessments, submission strategy, and submission writing
- Experience with regulatory strategies and/or submission planning with shifting timelines
- Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, packaging, or sterilization
- Experience with direct people leadership
- Ability to prioritize work and adapt to shifting priorities
- Demonstrated communication and organizational skills
- ability to travel up to 15%
Desired Qualifications
- Experience with Custom Made Device and/or Patient Matched device regulatory requirements and pathways
- Experience with regulatory clinical pathways including IDEs
- Advanced degree
- RAC certification
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