SENIOR REGULATORY COUNSEL - JD WITH FDA, EPA, NIOSH OR CPSC KNOWLEDGE
$180K - $200K + Bonus + Benefits inc Relocation
We are recruiting for a global manufacturer & distributor looking to recruit a Senior Regulatory Counsel to manage & provide guidance and strategic support on legal matters related to the successful operation of a multinational company's global quality, regulatory, and product safety functions across the Company’s diverse product portfolio. Reporting to the Assistant General Counsel, duties include;
- Provide sound balanced legal advice on a wide range of quality, regulatory compliance, and product safety matters.
- Serve as a key member of the legal center of excellence supporting global Quality, Regulatory and Compliance (“QRC”) function and business units & commercial legal teams.
- Provide advice on product development and marketing activities as they relate to quality, regulatory compliance, and product safety issues.
- Ensure the governance, integrity and effectiveness of QRC compliance programs.
- Provide counsel in responding to and managing significant agency inquiries and inspections, and support the handling of significant quality events.
- Establish a proven business partnership with the QRC leadership and governance teams and the leadership teams of each of the business units.
- Partner with QRC teams to assist in monitoring external regulatory environment and key developments, and provide counsel in developing policies, procedures, programs, legal guidance documents, tools and training materials.
- Work collaboratively with global commercial legal teams and Litigation center of excellence in support of global quality, regulatory compliance, and product safety issues.
You should have a JD (or equivalent) and be admitted to practice in at least one U.S. state bar, with at least seven years of experience at a top-tier international law firm or else in-house with a large multi-national company. You must be used to counseling clients (external or internal) on governmental regulations including some of FDA, EPA, NIOSH or CPSC regulations and used to liaising with (or even working for) such regulators. You should also have some experience of quality, regulatory compliance or product safety matters across one or more of medical devices, PPE, biocides, disinfectants, cosmetics and/or consumer products.
So, if that sounds like you, then please send your details to our MD, David Symes FCA, at (including a contact no and ideally evidencing how you meet the above criteria) however please note due to COVID-19 we cannot reply to all applications so only successful applications will be contacted (although under no circumstance are your details ever passed on without your specific permission).