Senior RA Specialist

Senior Regulatory Affairs Specialist

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.

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Job Description

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.

Minimum Qualifications

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.

Preferred Qualifications

Advanced degree (MS, PhD, or RAC certification).

Demonstrated success in the preparation and completion of regulatory submissions (Q-Sub, PMA, IDE) to FDA and other global regulatory agencies.

Experience negotiating with regulatory authority personnel (e.g., FDA, Notified Bodies).

Familiarity with STED format and technical file updates for CE marking under EU MDR.

Experience supporting regulatory strategy throughout the product lifecycle.

Hands-on experience with EU regulatory submissions, including preparation and maintenance of technical documentation under EU MDR.

Demonstrated success in the preparation and completion of multiple 510(k) submissions.

Experience working with FDA personnel during 510(k) review and meetings with the Agency.

Proven ability to resolve problems and make appropriate regulatory decisions.

Experience supporting development and execution of global regulatory strategies in collaboration with international RA teams.

Knowledge, Skills, and Abilities

Ability to develop regulatory strategies for Change Controls (CC) and establish regulatory requirements.

Strong cross-functional collaboration and influencing skills.

Current knowledge of U.S. and European medical device regulations.

Strong technical writing skills and ability to compile successful submissions for the appropriate audience.

Ability to maintain confidentiality in handling regulatory and clinical documentation.

Strong prioritization, multitasking, and independent work skills.

Strong critical thinking, communication, and project management skills.

Ability to function effectively in a matrix organization.

Ability to mentor and teach other regulatory associates.

Proven experience owning and managing the end-to-end process of authoring, submitting, and obtaining regulatory approvals / clearances (e.g., 510(k)s), including responding to agency deficiencies.

Proficient in Microsoft Office tools (Word, Excel, PowerPoint) and Adobe.

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. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.