Senior Regulatory Counsel
The Senior Regulatory Counsel position is responsible for providing legal advice on various healthcare laws, rules, and regulations impacting the products and services offered by the company. Additionally, this role involves managing other regulatory responsibilities as assigned, ensuring adherence to applicable laws and regulations.
Key Responsibilities:
- Advise cross-functional teams across the business on a broad variety of healthcare regulatory issues and considerations related to legal risks.
- Represent the company in FDA, DEA, state Boards of Pharmacy and other enforcement agency audits and investigations
- Manage FDA, DEA and state board of pharmacy licensing process by developing and implementing strategic initiatives to streamline processes, ensure timely renews, and maintain compliance with evolving regulatory requirements
- Assume full responsibility for overseeing all aspects of the VAWD application, accreditation, and renewal activities, including the development of comprehensive work instructions to guide the accreditation process and ensure adherence to VAWD standards
- Stay up to date on relevant state and federal laws, and regulations related to medical device and pharmaceutical distribution
- Manage the company's product complaint and recall process.
Qualifications:
- Juris Doctorate from an accredited academic institution
- Minimum of 5 to 8 years of experience in the legal field
- Proven supervisory experience and industry-specific knowledge
- Ability to collaborate cross-functionally (e.g. Senior Leadership, sales, marketing, IT, HR, finance, customer service, warehouse) to achieve compliance and sustainability objectives
- Proven ability to draft clear and complex policies, processes, procedures
FAQs
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