BD

Staff Regulatory Affairs Specialist

BD

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California, New Jersey • 🇺🇸 United States

Visit company website
✨ AI Apply
Apply

Salary

💰 $124,700 - $205,800 per year

Job Level

Lead

About the role

  • Represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on compliance projects
  • Coordinate, prepare, and complete premarket applications to the US FDA
  • Act as liaison with FDA regarding product submissions
  • Assess US regulatory requirements for proposed device modifications
  • Prepare robust non-filing justifications for changes that do not require a 510(k) submission
  • Support technical files for submission to European Notified Bodies for timely CE marking of new and modified products
  • Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies
  • Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates
  • Lead regulatory efforts required to align with new regulations and requirements
  • Review and approve product labeling, promotional, and advertising materials to ensure regulatory compliance
  • Prepare, submit, and maintain global regulatory submissions and registrations
  • Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards
  • Coordinate and respond to customer requests for product information.

Requirements

  • Bachelor’s degree, preferably in a life sciences field
  • Advanced degree preferred
  • Minimum of 5 years Regulatory Affairs experience in medical devices, preferably sterile single-use disposable products
  • Proven ability to resolve problems and make appropriate regulatory decisions
  • Demonstrated success in the preparation and completion of 510(k) submissions
  • Experience collaborating with FDA personnel during 510(k) review and meetings with the Agency
  • Extensive knowledge of US medical device regulations including 21 CFR 820 - Quality System Regulation / design controls, consensus standards, and FDA guidance documents
  • Current knowledge of European quality system standards and requirements under MDD and MDR
  • Proficient in using Microsoft Outlook, Word, Excel, PowerPoint, and Adobe.
Benefits
  • Annual Bonus Potential
  • Discretionary LTI 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
  • Other Well-being Resources
  • 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
  • Other Life Balance Programs
  • 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
  • Leave Programs
  • 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 Affairspremarket applications510(k) submissionsnon-filing justificationsglobal regulatory strategiesproduct labeling compliancestandard operating proceduresrisk assessmenttechnical file preparationregulatory decision making
Soft skills
problem solvingcommunicationcollaborationleadership