[Remote] Part-Time, Interim Commercial and Regulatory Counsel
Note: The job is a remote job and is open to candidates in USA. Major, Lindsey & Africa’s Interim Legal Talent group is seeking a part-time, interim commercial and regulatory counsel for a well-respected medical laser and device manufacturer. The role focuses on providing legal advice on commercial and regulatory issues in the medical device manufacturing space, ensuring compliance with various regulatory requirements.
- Responsibilities
- Provide the client advice on a host of medical device legal and regulatory requirements, including, but not limited to: Quality System Regulation, FDA (21 CFR Part 820), Medical Device Regulation (MDR), ISO 13485, Health Insurance Portability and Accountability Act (HIPAA), Foreign Corrupt Practices Act (FCPA)/anti-bribery laws, anti-kickback laws, Sunshine Act and transparency laws, False Claims Act, and Office of Inspector General (OIG) General Compliance Program
- Partner with client’s research and development team on product submissions and advise on (510(k), pre-market approval (PMA), Customer Engagement (CE) marketing, labeling, advertising, audits, and inspections
- Support legal aspects of clinical trials, post-market surveillance, and cybersecurity compliance
- Skills
- Ten or more years' experience acquired in a top law firm and/or in-house environment advising on regulatory issues and negotiating commercial agreements to ensure compliance with said regulatory requirements
- Excellent academic and professional credentials including a law degree from a well-respected, accredited US based law school
- Admission to at least one state bar in active and good standing. Proof of same will be required
- Ten or more years' experience acquired in a top law firm and/or in-house environment advising medical device clients on regulatory and contractual issues
- Command of the following: FDA regulations, MDR, ISO 13485, HIPAA, FCPA/anti-bribery laws, anti-kickback laws, Sunshine Act and transparency laws, False Claims Act, OIG General Compliance Program and applicable global laws
- Deep experience in contract negotiation
- Company Overview
- Major, Lindsey & Africa is the world’s leading legal search and talent solutions firm. It was founded in 1982, and is headquartered in Hanover, Maryland, US, with a workforce of 201-500 employees. Its website is https://www.mlaglobal.com.
Apply Now
Apply Now