Staff Regulatory Affairs Specialist at BD
Franklin Lakes, New Jersey, USA -
Full Time


Start Date

Immediate

Expiry Date

17 Oct, 25

Salary

215200.0

Posted On

18 Jul, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Project Teams, Health Sciences, Completion, Regulatory Agencies, Thinking Skills, Confidentiality, It, Microsoft Word, Creativity, Ownership, Timeline Development, Regulatory Submissions, Excel, Powerpoint, Clinical Documentation, Product Life Cycle, Healthcare Industry

Industry

Pharmaceuticals

Description

JOB DESCRIPTION SUMMARY

Staff Regulatory Affairs Specialist – Franklin Lakes NJ
BD Specimen Management (SM) offers a comprehensive range of solutions spanning the entire specimen management continuum and beyond—starting with the clinically-differentiated BD Vacutainer® range of blood and urine specimen collection and specimen management products, to sample analysis and accurate reporting. 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.

QUALIFICATIONS:

  • B.S. degree in a scientific, health sciences or technical discipline required (e.g., engineering, bioengineering, biology, chemistry).
  • Minimum 5 years Regulatory Affairs experience in medical device or in vitro diagnostic device companies or an equivalent combination of experience with an advanced degree prefferred.
  • Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global regulatory agencies and experience negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) preferred
  • Must demonstrate ability to provide regulatory support through the product life cycle on cross-functional product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission related documents).
  • Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
  • Familiarity with STED and/or technical file updates for CE marking activities and notified body interactions to maintain EU/MDR and/or EU/IVDR product registrations
  • Preferred experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.

KNOWLEDGE AND SKILLS:

  • Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
  • Strong communication (written, oral), project management, and critical thinking skills.
  • Demonstrated cross-functional collaboration and teamwork skills including influencing without authority.
  • Must have current knowledge of the U.S. and European medical device regulations.
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
  • Must be able to prioritize and handle several projects concurrently.
  • Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.
    At BD, we prioritize on-site collaboration because we believe it cultivates 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.
Responsibilities
  • Coordinate, prepare, and complete premarket applications to the US FDA, including Premarket Notification [510(k)], Pre-Sub, and De Novo submissions in a timely manner. Act as liaison with FDA regarding product submissions. Experience in Safer Technologies Program (STeP), Breakthrough Device designation, and Predetermined Change Control Plans (PCCPs) is a plus.
  • Assess necessity for submitting a 510(k) application for proposed device modifications. Prepare robust non-filing justifications for changes that do not require a 510(k) submission.
  • Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
  • Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.
  • Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to partners.
  • Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development.
  • Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements.
  • Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
  • Lead regulatory efforts required to follow new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
  • Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
  • Coordinate and respond to requests for product information, and questionnaires requested by customers.
  • Ensure FDA device listings and facility registrations are maintained.
  • Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
  • Represent BD in relevant external trade organizations and lead/participate in regulatory standards development/compliance activities as necessary to support BD’s continuous product development and compliance efforts.
  • Identify ways to improve the efficiency of current work process and implement them.
  • Carry out the above tasks with limited supervision.
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