About the Role: We are looking for a passionate, engaged, and proactive leader to join our Regulatory team. In this role, you will lead the Post Market Regulatory team.

 

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

 

Responsibilities:  Provide leadership to the Post Market Surveillance and Labeling Regulatory team Routinely interact and coordinate with Quality, Regulatory, Product Specialist, and other leadership teams to ensure clarity of roles and responsibilities and identify improvements to post-market processes Ensure regulatory subject matter expertise is in place to interpret global post-market (including proactive surveillance, complaint handling, and field actions) and other labeling regulatory requirements and support the implementation of compliant policies and procedures Monitor regulatory post-market, and labeling process performance and coordinate with other functional teams to resolve compliance issues, as well as identify and implement opportunities for process improvement Ensure regulatory subject matter expertise is in place to provide guidance to post-market surveillance coordinators, respond to requests from regulatory authorities regarding post-market activities, and support the conduct of field actions Participate as a member of applicable post-market and labeling steering teams Exhibit role model behavior consistent with our culture and leadership practices in support of our brand promise of Together, Improving Life Establish clear expectations of equitable and inclusive behaviors from Associates and act immediately to appropriately address negatively impactful or unfair behavior

Required Qualifications: 

Bachelor’s degree in biological, chemical, engineering, medical, legal, or allied health sciences field Minimum 5 years of experience working in a medical-device role involved in the application of regulations and standards Demonstrated experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices Success leading complex projects or diverse teams Demonstrated strategic mindset towards driving operational efficiency Demonstrated knowledge of Medical Device Post Market requirements and complaint process Knowledge of global regulatory processes including FDA and EU submission requirements Strong communication skills (oral, written, and interpersonal) adaptable to circumstance and audience Ability to influence stakeholders to effect change and achieve business objectives (including regulatory agencies/competent authorities Ability to travel as necessary domestically and internationally to achieve business and project objectives (<10%)

 

Desired Qualifications: 

Direct experience with global post-market adverse event reporting and/or medical device field actions Direct experience with global regulatory submissions

 

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

Additional Information Travel%: 10 Shift: Day Job Schedule: Full-time Posting End Date: Jan 17, 2025