[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
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