Regulatory Affairs Manager

About the Role

We are looking for a Regulatory Affairs Leader to join our team with the Aortic Business Group. In this role, you will p lan, 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. In addition, you will p rovide direction and leadership for Regulatory Associates with a focus to develop global regulatory strategies and provide guidance and support for comprehensive global submission planning.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities

• Provide direction for regulatory team members for both pre- and post-market product strategies, comprehensive submission planning, regulatory agency discussions, and approval timelines
• Provide management and leadership for Regulatory Associate’s goals, objectives, projects and responsibilities
• 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
• Work together with cross-functional teams (e.g., Clinical, Product Specialists, and Technical) to ensure open communication and that expectations are being met
• Partner with Regulatory Affairs Business Leader to ensure business and regulatory goals are met
• Share regulatory knowledge and experience to assist Regulatory Associates in developing expertise on regulatory deliverables and requirements, including labeling, promotional advertising, and other regulatory compliance areas
• Ensure communication of changing global regulatory requirements both within the function and with other functional teams
• Additional responsibilities as required within the scope of position

Required Qualifications

• Bachelor’s degree and 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 and 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 and 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 or RAC certification

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

* Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.