[Remote] Part-Time, Interim reputed company and Regulatory Counsel

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