Regulatory Affairs Product Manager
About the Role: We are looking for a Regulatory Affairs Product Manager 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; provide 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.
- 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 the Medical Products Division 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 Product Group 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
- Maintain compliance with training expectations as required for this position
- Perform additional responsibilities as required within the scope of position
- Establish clear expectations of equitable and inclusive behaviors from Associates and acts immediately to appropriately address negatively impactful or unfair behavior
Required Qualifications:
- Bachelor’s degree; and a minimum 5 years of experience in medical device Regulatory Affairs
- Experience actively working with cross-functional teams to influence the direction and meet timelines
- Experience with regulatory strategies and/or submission planning with shifting timelines
- Regulatory knowledge specific to assessing post market device changes
- Proven track record in managing complex global regulatory strategies
- Willingness to share experience and coach other Regulatory Associates in order to successfully execute on regulatory assessments, submission strategy, and submission writing
- Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, packaging, or sterilization
- Demonstrated communication skills (oral, technical writing, and interpersonal)
- Attention to detail; and good organizational skills with the ability to prioritize work and adapt to shifting priorities
- Ability to interact effectively with many diverse functional groups
Desired Qualifications:
- Advanced degree in a biological, chemical, engineering, medical, legal or allied health sciences field
- Hands-on experience with PMA products and other high-risk products
- Experience leading a team or direct people leadership
Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
#LI-MSL
#LI-Remote
About Gore
For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development.