Associate Legal Director, B2B

embecta•Parsippany, NJ

1d•Hybrid

About The Position

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. The Associate Legal Director, B2B serves as a strategic legal advisor supporting B2B commercial operations, Regulatory Affairs, Research and Development (R&D), and Medical Affairs in a highly regulated medical device environment. This role partners with the Commercial teams by providing practical, business focused legal counsel to support the strategy of growing into a broad-based medical supplies organization. The attorney will offer guidance on complex legal and regulatory issues, including advertising and promotion, fraud and abuse, and other healthcare laws. Provide strategic input that enables innovation and business growth while managing legal risk and safeguarding the company’s integrity. This role will sit hybrid two days a week in our Parsippany, NJ office

Requirements

Juris Doctor (JD) from an accredited law school.
Undergraduate degree in a relevant technical or scientific field (engineering, biology, chemistry, biomedical sciences preferred).
6+ years of corporate and functional law experience in in combination of law firms and life science companies.
Active membership in at least one U.S. state bar.
Strong understanding of global regulatory frameworks (e.g., EU MDR).
Advanced B2B contract drafting and negotiation skills.
Ability to translate regulatory and R&D requirements into practical business guidance.
Strong analytical and risk‑assessment skills across the product lifecycle, including understanding of intellectual property (Patent Bar not required).
Demonstrated ability to balance legal, compliance, and business considerations.

Nice To Haves

Excellent written, oral, and cross‑functional communication abilities.
Able to manage multiple priorities in a fast‑paced, highly regulated environment.
Collaborative, solutions‑oriented working style with technical and commercial teams.
Adaptable to evolving regulations and changing business needs.
Effective project management and organizational skills.
Proactive in identifying risks, opportunities, and process improvements.
Self‑motivated, reliable, and able to work independently with sound judgment.
Strong interpersonal skills and professionalism; effective influencer.
Comfortable working across diverse subject‑matter areas and learning new domains.
Commitment to ethical conduct and high‑quality execution under pressure.

Responsibilities

Advise business leaders as they develop comprehensive strategies and tactics that harmonize with our strategy and resonate effectively across all teams.
Enable cross‑functional collaboration between R&D, Regulatory, Clinical, Quality, and Commercial teams to ensure smooth transition from early development to later‑stage programs.
Demonstrate strategic business ownership, external awareness, proactive counseling, innovation, and value creation in stakeholder interactions.
Work closely with colleagues across Legal, Ethics & Compliance, Commercial, Regulatory, R&D, Medical Affairs, external vendors and outside counsel.
Deliver additional legal support as needed to advance organizational priorities and initiatives
Partner with Regulatory Affairs leaders to execute regulatory strategy aligned with FDA and global medical device requirements.
Interpret and apply regulatory frameworks including 21 CFR Part 820, Part 11, device classification rules, and submission standards.
Support and review regulatory submissions including 510(k), PMA, De Novo, and international filings.
Advise cross‑functional teams throughout the product lifecycle on regulatory impacts and risk mitigation.
Provide legal counsel to R&D teams on product innovation, development pathways, and early‑stage feasibility assessments.
Advise on regulatory implications for R&D strategy, including clinical development planning, design controls, and documentation requirements.
Support the creation, review, and negotiation of R&D‑related agreements, including research collaborations, sponsored research, CRO/consultant agreements, material transfer agreements (MTAs), and technology evaluations.
Ensure R&D activities align with applicable regulatory and ethical standards, including human subject protections, data integrity requirements, and device/technology development guidelines.
Partner with engineers, and program managers to proactively identify legal and regulatory risks during concept development and prototype testing.
Provide guidance on intellectual property strategy in coordination with IP counsel, including invention disclosures, freedom‑to‑operate considerations, and technology landscape assessments.
Counsel teams on compliant generation, handling, and sharing preclinical, clinical, and technical data.
Support due diligence for emerging technologies, platforms, and external research partnerships.
Draft, negotiate, and manage commercial agreements including supply, OEM, distribution, licensing, and quality agreements.
Provide legal counsel on partnerships, joint ventures, strategic initiatives, and related transactional matters.
Manage pre‑litigation disputes and coordinate with external counsel when appropriate.
Serve as primary legal contact for assigned assets/business units, including review of advertising, promotional, and scientific exchange materials.
Act as a strategic partner to the business in developing and executing initiatives and managing associated legal risks.
Coordinate contract review and negotiation across diverse subject matter areas, engaging SMEs where necessary.
Support adherence to internal policies and monitor legislative developments impacting the business.