Staff Regulatory Affairs Specialist

BD

Franklin Lakes, NJ, USA
Base: $130,400.00 - $215,200.00 usd annual; bonus/...
Hybrid
Us and ce marking submissions
Product sustaining activities
Global regulatory strategies
The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide

Job Summary

  • The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
  • Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Matching Summary

The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.

Salary

Base: $130,400.00 - $215,200.00 USD Annual; Bonus/Equity: Not specified; 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, Retirement and Financial Well-being programs, Paid time off, Educational assistance, 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

Skills & Requirements

Must-have

  • US and CE marking submissions
  • product sustaining activities
  • global regulatory strategies
  • medical device and in vitro diagnostic experience
  • US and European medical device regulations
  • technical writing skills

Nice-to-have

  • imagination and passion
  • human element
  • cross-functional collaboration and teamwork
  • influencing without authority
  • self-motivated by working independently

Key Requirements

  • B.S. degree in scientific, health sciences or technical discipline
  • Minimum 5 years Regulatory Affairs experience
  • Demonstrated success in regulatory submissions
  • Ability to provide regulatory support through product life cycle
  • Familiarity with STED and/or technical file updates

Work Rights

Not specified

Tailored Resume

Cover Letter