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BD · 2 months ago

Senior RA Specialist

Franklin Lakes, NJ

Full-time

Onsite

Senior Level

$107K/yr - $176K/yr

5+ years exp

BD is one of the largest global medical technology companies in the world, and they are seeking a Senior Regulatory Affairs Specialist to represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery platform. This role involves supporting compliance projects, product engineering, new product development, and other regulatory-related initiatives.

Health CareMedical DeviceTechnical Support

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

Qualification

Regulatory AffairsFDA submissionsEU MDR complianceMedical device regulationsRegulatory strategyTechnical writingCross-functional collaborationProject managementMicrosoft OfficeCommunication skillsCritical thinkingMentoringProblem-solving

Required

Bachelor's degree in a scientific, health sciences, or technical discipline (e.g., Regulatory Affairs, Quality Assurance, Engineering, Bioengineering, Biology, Chemistry)

Minimum of 5 years of Regulatory Affairs experience in medical devices, preferably sterile single-use disposable products