The Senior Regulatory Affairs (RA) Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform of the Medication Delivery Solutions business unit at Becton Dickinson (BD). This role supports compliance projects, product engineering, new product development, and other regulatory-related initiatives and maintenance activities.
Requirements
- Represent Regulatory Affairs on product development teams to support new product development and change control, ensuring compliance with US, EU, and other global regulatory requirements.
- Author FDA submissions (e.g., 510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings.
- Evaluate medical device regulations and lead the development of global regulatory strategies to bring products to market.
- Review and approve design control documentation in consideration of US, EU, and other global regulatory requirements.
- Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
- Serve as a point of contact for FDA, EU Notified Bodies, and other regulatory agencies regarding submissions and related issues.
- Independently assess product changes for regulatory impact, including US and CE Mark implications, and prepare resulting notifications or non-filing justifications.
- Communicate regulatory changes to global regions and support preparation of global notifications as needed.
- Stay informed of new and evolving global regulatory requirements and communicate relevant updates to project teams.
- Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to collaborators.
- Lead regulatory efforts required to align with new regulations and standards (e.g., EU MDR, IVDR, MDSAP).
- Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Demonstrate working knowledge of regulations for sterile Class II devices, preferably related to IV infusion disposables.
- Draft and deliver RA-related training for the RA group and/or cross-functional business collaborators (e.g., Marketing, Medical Affairs, R&D).
- Identify current work process inefficiencies and implement improvements.
- Execute the above tasks with limited supervision.
Benefits
- Annual Bonus
- Health and Well-being Benefits
- 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
- Baxter Credit Union (BCU)
- 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
