Staff Regulatory Affairs Specialist
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Job Description
Regulatory Affairs Specialist guiding FDA, CE, and global submissions for BD’s medical device and diagnostic portfolios. Maintaining market access and regulatory compliance across product lifecycles.
Responsibilities:
- Coordinate, prepare, and complete premarket applications to the US FDA, including 510(k), Pre-Sub, and De Novo submissions
- Act as liaison with FDA regarding product submissions
- Assess whether proposed device modifications require a 510(k) application
- Prepare non-filing justifications for changes that do not require a 510(k) submission
- Coordinate and prepare technical files for European Notified Bodies for CE marking of new and modified products
- Provide regulatory leadership and guidance to cross-functional product development teams
- Identify and communicate quantified regulatory risks and mitigation approaches
- Manage Notification of Change and International Regulatory Affairs assessments for sustaining activities
- Develop regulatory strategies for Change Controls and establish Regulatory Requirements
- Support global regulatory strategies and collaborate with international regulatory associates
- Lead regulatory efforts for new regulations and international standards, including EU MDR/IVDR and MDSAP
- Review and approve product labeling, promotional materials, and advertising materials
- Coordinate responses to customer product-information requests and questionnaires
- Maintain FDA device listings and facility registrations
- Develop and maintain SOPs, work instructions, and policies
- Represent BD in external trade organizations and support regulatory standards development and compliance activities
- Improve the efficiency of current work processes
Requirements:
- B.S. degree in a scientific, health sciences or technical discipline required (e.g., engineering, bioengineering, biology, chemistry)
- 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies
- Proficient in technical writing skills and compiling successful submissions for the appropriate audience
- Experience maintaining confidentiality in dealing with regulatory and clinical documentation
- Experience with cross-functional collaboration and teamwork skills including influencing without authority
- Proficient in Microsoft Word, Excel, and PowerPoint
Benefits:
- Medical, dental, vision, health savings and flexible spending accounts
- Life and disability insurance
- Wellness resources
- Mental health support and disease management programs
- 401(k)
- Deferred compensation programs
- Financial counseling
- DailyPay
- Educational savings resources
- Paid time off
- Company holidays
- Educational assistance
- Parental leave
- Adoption assistance
- Backup care
- Caregiving support
- Employee assistance programs
- Commuter benefits
- Pet insurance
- Legal services
- Associate discount programs
- Bereavement, military, personal, family and medical leave, and jury duty leave
- Reward and recognition opportunities
- Competitive compensation and benefits programs
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