Senior Legal Counsel, Regulatory Emea
vor 2 Monaten
**Job Description Summary**: The Senior Counsel, Regulatory Law EMEA, will be a member of the EMEA Law Group and will report to Chief Regional Counsel EMEA and EMEA-based businesses with a strong dotted line to the VP Compliance Officer and Chief Regulatory Counsel.
**We are the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
**Why Join Us?**
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us
**Position Responsibilities will include, but are not limited to, the following**:
- Provide expert advice and counsel to supported businesses concerning complex regulatory matters with a focus on MDR/IVDR and medical device regulations in the EMEA region.
- Advise on legal issues throughout the medical device life cycle related to recalls, promotion and advertising, clinical studies, medical device reporting, drug adverse event reporting, corrections and removals, product clearance and approvals, inspections, and quality system compliance.
- Maintain knowledge of current medical device and drug regulatory law, pending legislative and regulatory changes, and enforcement actions to maintain the highest level of expertise.
- Provide legal counsel to clients on a variety of regulatory and quality matters, including pre-market approval and post-market surveillance, promotional issues, product development issues and other regulatory matters.
- Provide legal counsel during regulatory agency investigations and/or administrative actions brought against the Company with particular emphasis on regulatory issues.
- Provide legal advice and guidance on global trade matters, including import/export compliance, customs, supply chain, and global trade regulations.
- Review and provide legal guidance on the implementation of the Company’s global trade compliance programs and policies.
- Monitor and analyze legal and regulatory changes in global trade laws and regulations and advise the Company’s business leadership on the legal impact of such changes.
- Provide day to day legal advice and oversight to a variety of constituents including management, customers, and governmental officials on a range of EH&S matters.
- Understand and be able to translate into “plain English” the legal ramifications of varied legal and regulatory risks.
- Ability to contemplate the legal implications of new innovations and collaborate with the business to develop regulatory strategies for new technologies.
- Develop strong relationships throughout all functional areas, departments, and divisions to foster an advisory or collaborative approach to proactive compliance.
- Knowledge of EU REACH, CSRD and CS3D preferred.
- Commercially oriented, understanding the nuances of complicated regulatory issues and able to think creatively to solve problems and mitigate risk while supporting business objectives.
- Keeps up to date on all current and pending environmental, health and safety legislation and regulations.
- Support regulatory due diligence for new business and product acquisitions.
The position is ideal for a detail oriented, knowledgeable, independent, self-starter who is interested in achieving a high degree of success in a collaborative environment.
**Qualifications**:
- Master degree from an accredited law school. Licensed to practice law in an EU memberstate.
- At least 5 years of relevant experience in regulatory and/or trade law.
- Working knowledge of EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) and experience advising clients on U.S. and/or EU medical device regulatory law is required.
- Experience advising clients relating to Quality System regulations, Good Manufacturing Practices (GMPs), EU Drug Safety/Pharmacovigilance, and clinical trials preferred.
- Experience on EU trade regulations is a plus.
- A demonstrated ability to lead through influence and navigate controversial situations and negotiations.
- Excellent analytical, communication, and drafting s
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