Legal Counsel, Regulatory/Life Sciences - Remote

W. L. Gore & Associates is seeking a regulatory attorney to join our Global Legal Team. In this role, you will provide life sciences-based regulatory legal advice and support for Gore Medical. Your practice will include counseling business partners and providing oversight to ensure medical devices are developed, manufactured, marketed, and distributed in compliance with laws, regulations, and ethical guidelines that govern medical products across the world. This position requires knowledge of the laws and regulations applicable to clinical research, product development, product approval, manufacturing (FDA QSR/ISO 13485 and cGMP), advertising and promotion (including social media and health economics), anti-kickback statutes, false claims, reimbursement and payers, data privacy and HIPAA/HITECH. This senior counsel-level position will collaborate closely with other members of the Gore Medical Legal, Compliance & Data Privacy team, as well as the Regulatory Affairs, Clinical, Office of Medical Affairs, Health Economics & Reimbursement, Quality, and Marketing teams.

This position offers flexible work arrangement options: on-site at our facility in Flagstaff or Phoenix, Arizona, hybrid or fully remote in most locations within the United States.

• Provide practical advice to allow Gore to meet its objectives through interpreting and applying the laws and regulations applicable to its medical business
• Respond to routine regulatory inquiries, new product submissions, inspections and audits by government agencies (including experience with FDA and MDSAP)
• Provide transactional advice and drafting related language for contracts that involve life sciences topics (e.g., research, product development, procurement, third party manufacturing, mergers and acquisitions)
• Identify issues and coordinate legal advice with team members for related life sciences issues, such as data privacy, ethics and compliance, product liability and litigation, anti-bribery and corruption, intellectual property and anti-trust law
• Partner closely with other legal team members to provide efficient and integrated legal advice to business and functional clients
• Coordinate legal advice for matters with regional or global implications, including marketing and promotional activities
• Develop and deliver internal training on legal and regulatory topics
• Monitor compliance with current life sciences related Enterprise policies and procedures
• Assist with or lead investigations and resolve reports of alleged regulatory or life sciences related non-compliance; develop and implement appropriate corrective action plans
• Monitor and evaluate regulatory developments from government agencies and advisory bodies and industry trends to determine needed changes and to develop proactive approaches to emerging industry issues

• Juris Doctorate degree from an accredited university, admitted to practice in good standing in at least one U.S. state
• Minimum 4 years of relevant legal or regulatory work experience in advising clients in a regulated life sciences business
• Demonstrated knowledge of FDA laws and regulations, standards and guidance applicable to medical devicesorother regulated products
• Excellent writing, communication, and organizational skills
• Strong business acumen, and understanding of strategic and tactical business issues
• Ability to relay complex legal concepts and principles to non-legal business stakeholders and partners
• Ability to work and problem-solve independently, as well as collaboratively, as part of a team in a matrixed organization
• Ability to work with multiple functional areas, cultures, and nationalities; flexibility to prioritize and handle multiple tasks/projects
• Ability to travel up to 20%, including international destinations

• Prior in-house medical device or government (FDA) experience
• Prior experience with similar agencies and requirements in jurisdictions in other regions where Gore does business (e.g., Europe, Middle East, Japan, Asia Pacific, South and Central America)
• Preference for experience with Class III medical devices, digital health, and market access as related to reimbursement and payer matters

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.