Regulatory Affairs Product Manager - Remote
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
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