Interim Commercial and Regulatory Counsel

Major, Lindsey & Africa; Marlborough (MA); Hybrid; USD 100,000 - 160,000; Part time

Job summary

A leading company in medical device manufacturing seeks a part-time interim commercial and regulatory counsel in Marlborough, MA. The role requires extensive legal experience in regulatory compliance and contract negotiation, focusing on medical devices. Candidates should hold a law degree and be admitted to a state bar.

Qualifications

• 10 years' experience in top law firm or in-house advising medical device clients.
• Admission to a state bar in good standing required.
• Command of FDA regulations, MDR, HIPAA, FCPA, and others.

Responsibilities

• Provide legal advice on medical device regulatory compliance.
• Partner with R&D on submissions and compliance issues.
• Support clinical trials and cybersecurity compliance.

Skills

Contract Negotiation

Regulatory Compliance

Advising on Medical Device Law

Education

Law degree from an accredited US law school

Job description

Major, Lindsey & Africa’s Interim Legal Talent group has an immediate need for a part-time, interim commercial and regulatory counsel.
Overview: Our client seeks a seasoned and skilled attorney focusing on commercial and regulatory issues in the medical device manufacturing space.
Company: Our client is a well-respected, Massachusetts based medical laser and device manufacturer.
Experience: 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.
Location: Hybrid (2 days in office); Marlborough, Massachusetts.
Responsibilities Include:

• 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.

Qualifications Include:

1. Excellent academic and professional credentials including a law degree from a well-respected, accredited US based law school.
2. Admission to at least one state bar in active and good standing. Proof of same will be required.
3. Ten or more years’ experience acquired in a top law firm and/or inhouse environment advising medical device clients on regulatory and contractual issues.
4. 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.
5. Deep experience in contract negotiation.

Information regarding benefits can be found on MLA’s Website on the Consultant Resources Page: https://www.mlaglobal.com/en/consultant-resources

All interested and qualified candidates should apply directly with Major, Lindsey & Africa for review and consideration.
Major, Lindsey & Africa does not discriminate against applications on the basis of age, sex, race or any other protected characteristics pursuant to applicable state or federal laws.