Regulatory Affairs Leader: Peripheral and Combination Products

Required Qualifications: 

• Bachelor's Degree in a biological, chemical, medical, engineering, legal or allied health-sciences field
• Minimum 10 years of directly applicable medical device regulatory affairs work experience, including 5 years of experience with US Class III devices
• Minimum 5 years of direct people leadership experience 
• Demonstrated experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
• Demonstrated experience developing multi-region regulatory strategies
• Success working across multiple geographies including, but not limited to, the U.S., Europe, Japan and China
• Excellent written and oral communication skills, manifested as the ability to express regulatory information accurately, clearly, and succinctly
• Demonstrated prioritization, organizational, and planning skills
• Demonstrated problem-solving and project management skills, including situations that include ambiguity
• Ability to travel as necessary domestically and internationally to achieve business and project objectives (15%)

Desired Qualifications: 

• Advanced degree
• Demonstrated success integrating, influencing and leading cross functional teams
• Experience with combination products (drug-device)

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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