Interim Commercial and Regulatory Counsel

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.

Information regarding benefits can be found on MLA’s Website on the Consultant Resources Page:

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.