Regulatory Affairs Manager - RA Strategy Lead; Hybrid

Regulatory Affairs Manager - RA Strategy Lead (Hybrid)

Join BD Nogales Norte as a Regulatory Affairs Manager – RA Strategy Lead (Hybrid). In this role you will work closely with the Director of Regulatory Affairs to provide proactive regulatory surveillance, develop regulatory strategies for product creation and market entry, and serve as the regulatory advisor to innovation teams.

This position supports the innovation council by providing upfront regulatory assessments to guide planning during concept and product development, helps in policy shaping, and ensures timely communication of regulatory changes to the organization.

• Proactively monitor global regulatory developments to identify potential impacts on the product portfolio, delivering timely and actionable insights to stakeholders.
• Collaborate with cross‑functional teams to develop plans addressing evolving regulations and standards that support product innovation and market entry.
• Serve as a regulatory advisor to innovation teams, providing mentorship on compliance and guidelines throughout the product lifecycle and facilitating knowledge sharing.
• Assess potential regulatory risks associated with product development and market strategies, proposing and implementing mitigation strategies.
• Effectively communicate trends in regulatory changes early to the organization, ensuring teams are prepared to adapt.
• Champion a culture of regulatory excellence by providing training and support to internal teams and fostering awareness of regulatory obligations.

• Bachelor’s degree required in Life Sciences, Engineering, or a related field.

• Minimum of 5 years of experience in regulatory affairs within the medical device industry.

• Comprehensive understanding of medical device regulations, standards, and the regulatory submission landscape (e.g., FDA, EU MDR, EU IVDR, ISO).
• Proven experience in developing and implementing regulatory strategies.
• Exceptional analytical and strategic thinking abilities.
• Strong communication and interpersonal skills with a proven ability to influence stakeholders.
• Effective project management skills and attention to detail.
• Proactive, adaptable, and results‑driven, with a passion for regulatory excellence and innovation.
• Ability to work collaboratively in a cross‑functional team environment.
• Knowledge of quality management systems and risk management principles.

$ – $ USD Annual

Franklin Lakes, NJ

Full‑time – Mid‑Senior level

Legal (Manufacturing)

• Annual Bonus
• Potential Discretionary LTI Bonus
• Health coverage (Medical, Dental, Vision)
• Health Savings Accounts
• Flexible Spending Accounts
• Hospital Care Insurance
• Critical Illness Insurance
• Accidental Injury Insurance
• Life and AD&DD insurance
• Short‑term and long‑term disability coverage
• Long‑term care with life insurance
• Health and Well‑being Resources (Anxiety management, sleep improvement, diabetes, virtual physical therapy, etc.)
• Retirement and Financial Well‑being (BD 401(k), Deferred Compensation, 529 Plan, etc.)
• Life Balance Programs (Paid time off, tuition reimbursement, pet insurance, commuter benefits, etc.)
• Leave Programs (Bereavement, Military, Family and Medical Leave, Jury and Witness Duty Leave)

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.