BD

Regulatory Affairs Manager – RA Strategy Lead

BD

full-time

Posted on:

Location Type: Hybrid

Location: Franklin Lakes • New Jersey • 🇺🇸 United States

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Salary

💰 $132,400 - $218,400 per year

Job Level

Senior

Tech Stack

Swift

About the role

  • Working closely with the Director of Regulatory Affairs, the Regulatory Affairs Manager – RA Strategy Lead will provide proactive regulatory surveillance.
  • They will develop regulatory strategies for product creation and market entry.
  • They will serve as the regulatory advisor on innovation teams.
  • This role is critical for proactively identifying regulatory changes and effectively communicating them to the business.
  • Ensure swift understanding and compliance planning.
  • Support the innovation council by providing upfront regulatory assessments to help guide planning through timely concept and product development.
  • Engage in policy shaping to allow the business to navigate the regulatory landscape effectively.
  • Proactively monitor global regulatory developments to identify potential impacts on product portfolio.
  • Deliver timely and actionable insights to stakeholders, ensuring alignment with business strategy.
  • Collaborate with cross-functional teams to develop plans addressing evolving regulations and standards that support product innovation and entry into markets.
  • Serve as a regulatory advisor to innovation teams, providing mentorship on compliance and guidelines throughout the product lifecycle.
  • Facilitate knowledge sharing to integrate regulatory considerations early in the development process.
  • Assess potential regulatory risks associated with product development and market strategies.
  • Propose and implement mitigation strategies to safeguard our innovation efforts.
  • Responsible for effectively communicating trends in regulatory changes early to the organization.
  • Ensure that all teams are informed and prepared to adapt to upcoming changes, fostering a proactive compliance culture.
  • Champion a culture of regulatory excellence by providing training and support to internal teams.
  • Foster awareness and understanding of regulatory obligations across the organization.

Requirements

  • 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.
Benefits
  • Annual Bonus Potential
  • Discretionary LTI Bonus
  • Medical coverage
  • Health Savings Accounts
  • Flexible Spending Accounts
  • Dental coverage
  • Vision coverage
  • Hospital Care Insurance
  • Critical Illness Insurance
  • Accidental Injury Insurance
  • Life and AD&D insurance
  • Short-term disability coverage
  • Long-term disability insurance
  • Long-term care with life insurance
  • Anxiety management program
  • Wellness incentives
  • Sleep improvement program
  • Diabetes management program
  • Virtual physical therapy
  • Emotional/mental health support programs
  • Weight management programs
  • Gastrointestinal health program
  • Substance use management program
  • Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
  • BD 401(k) Plan
  • BD Deferred Compensation and Restoration Plan
  • 529 College Savings Plan
  • Financial counseling
  • Daily Pay
  • College financial aid and application guidance
  • Paid time off (PTO), including all required State leaves
  • Educational assistance/tuition reimbursement
  • MetLife Legal Plan
  • Group auto and home insurance
  • Pet insurance
  • Commuter benefits
  • Discounts on products and services
  • Academic Achievement Scholarship
  • Service Recognition Awards
  • Employer matching donation
  • Workplace accommodations
  • Adoption assistance
  • Backup day care and eldercare
  • Support for neurodivergent adults, children, and caregivers
  • Caregiving assistance for elderly and special needs individuals
  • Employee Assistance Program (EAP)
  • Paid Parental Leave
  • Support for fertility, birthing, postpartum, and age-related hormonal changes
  • Bereavement leaves
  • Military leave
  • Personal leave
  • Family and Medical Leave (FML)
  • Jury and Witness Duty Leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory strategiesregulatory surveillanceregulatory submissionsmedical device regulationsFDAEU MDREU IVDRISOquality management systemsrisk management principles
Soft skills
analytical thinkingstrategic thinkingcommunication skillsinterpersonal skillsproject managementattention to detailproactiveadaptableresults-drivencollaborative