Responsibilities:

• Develop working knowledge of applicable domestic and international regulations and thorough familiarity and understanding of internal standard operating systems and procedures
• Provide regulatory Medical Device Reporting (MDR) to the FDA for Gore medical devices
• Communicate internally with local associates within the business, including product specialists, sales associates, quality assurance, engineering, and other related functional areas
• When dealing with international complaints, ensuring that any necessary reporting and communication occurs in an appropriate and timely manner
• Work with product teams to define/categorize potential complaints and MDRs based on training and anticipated and/or previously identified events
• Work with product teams to support periodic trend analyses as well as decisions and recommendations associated with corrective and/or preventive action(s), risk analysis/FMEA, revision/initiation of MDR reporting guidelines, and design control activity
• Maintain compliance with training expectations as required for this position
• Additional responsibilities as required within the scope of position

Required Qualifications:

• Bachelor's degree in a scientific discipline, OR minimum of 6 years of healthcare or medical device industry work experience, OR Bachelor's degree in a non-scientific discipline AND minimum of 3 years of healthcare or medical device industry work experience
• Experience in medical device reporting (MDR) submission to regulatory body
• Strong communication skills (verbal and written), experience with medical writing
• Attention to detail and organizational skills
• Solid, fundamental understanding of (or willingness to learn) medical terminology and anatomy
• Competency in Microsoft Office Suite
• Flexibility and ability to prioritize and handle multiple tasks/projects
• Ability to work and problem solve independently, as well as part of a team
• Ability to work with multiple functional areas in multiple physical locations
• Ability to work under and meet deadlines imposed by governmental regulations
• Ability to travel up to 10%

Desired Qualifications:

• Educational background and/or work experience in health care, or a related field

Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s hybrid working policies, from the country in which they are employed.

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-Hybrid

LI#-Hybrid

• Travel%: 10
• Shift: Day Job
• Schedule: Full-time
• Posting End Date: Aug 9, 2024