Regulatory Affairs Professional - Remote - Flagstaff Arizona

Company: W.L. Gore & Associates
Location: Flagstaff, Arizona
Posted On: 01/20/2025

About the Role: We are looking for a Regulatory Affairs Product Associate to join our team with the Aortic Business Group. In this role, you will p lan, 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. You will d evelop global regulatory strategies and prepare, write, coordinate, and interactively follow up on global submissions for implantable medical devices.

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

Responsibilities:

• Work closely with technical, regulatory affairs, research associates, and product specialists to develop strategies and approaches for obtaining and maintaining regulatory approvals
• Coordinate activities and timelines with applicable functional groups to complete regulatory submissions
• Evaluate product labeling, product claims, advertising, specifications, and changes for regulatory compliance
• Interact closely with and counsel functional groups in the business to provide regulatory guidance and review of their activities
• Integrate into the Regulatory Affairs team to facilitate collaborative and consistent regulatory counsel to product functional groups
• Represent Regulatory Affairs in quality system audits by external agencies
• Assist with post-market compliance requirements
• Collaborate with and counsel the clinical team to ensure notifications and other reports are submitted as required during the course of clinical trials
• Maintain compliance with training expectations as required for this position
• Additional responsibilities as required within the scope of position
  
  Required Qualifications:
  
  • Bachelor's degree and at least 3 years of Regulatory Affairs experience in the medical device industry
  • Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents
  • Knowledge of FDA and international regulations related to Class II and Class III implantable medical devices
  • Successful experience with submissions associated with device modifications and manufacturing process modifications and experience proactively identifying necessary submission content and assessing the project documentation, including compliance with international standards
  • Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, supplied components, packaging, or sterilization
  • Good communication (oral, written, and interpersonal skills)
  • Attention to detail and good organizational skills
  • Ability to interact effectively with many diverse functional groups
  • Ability to prioritize work and adapt to shifting priorities
  • Ability to travel up to 15%
    
    Desired Qualifications:
    
    • Experience with submissions for PMA products
    • Experience filing Class III device design dossiers under the European Medical Device Regulations, or filing submissions in another Tier 1 country
    • Experience with regulatory requirements for combination (drug/device) products and experience filing required notifications and reports during clinical trials
      
      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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