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Senior Regulatory Affairs Specialist

3 months ago

Warwick, Rhode Island, United States BD Full time
Job Description

Welcome to BD, one of the leading global medical technology companies. Our purpose is to advance the world of health, which is indeed a challenging task. From the conceptualization and engineering phases to the production and promotion of our vast range of MedTech products annually, every one of us contributes to turning innovative solutions into reality.

Join our community and explore an empowering environment where you are encouraged to learn, grow, and unleash your full potential. Be part of the team that makes possibilities come to life.

  • Provide regulatory support throughout the product life cycle on project teams, involving tasks such as developing regulatory strategies, managing timelines, implementing change control, and preparing submission-related documents.
  • Prepare and review 510(k)s, IDEs, PMA, and international submissions as necessary.
  • Create and maintain STED technical files for CE marking procedures and interact with notified bodies accordingly.
  • Identify and communicate well-defined risks and applicable mitigations related to regulatory strategies to various stakeholders.
  • Offer cross-functional assistance for regulatory compliance and submissions, including endorsing product labeling, promotional materials, and reviewing protocols.
  • Participate in internal and external audits and inspections for regulatory support.
  • Ensure prompt review and endorsement of product labeling and marketing claims to comply with regulatory standards.

Qualifications

  • Bachelor's degree in a technical field (e.g., engineering, biology, chemistry, health science) preferred. Consideration will be given to other fields with relevant experience.
  • Minimum of three years of Regulatory Affairs involvement with medical or in vitro diagnostic devices, demonstrating success in regulatory submissions. Alternatively, five years of experience in medical device functions with proven support for regulatory submission approval.

Knowledge, Skills, And Abilities

  • Proficiency in U.S. and European medical device regulations.
  • Strong written and verbal communication skills.
  • Self-motivated and capable of independent work with a sense of ownership.
  • Effective prioritization of multiple projects simultaneously.
  • Technical writing expertise and proven track record in compiling successful submissions.
  • Skilled in Microsoft Word, Excel, and PowerPoint.
  • Excellent communication, project management skills, and familiarity with regulatory standards.
  • Desirable to have RAC certification.
  • Desirable to have prior experience managing class III devices and knowledge of RIM.

At BD, we embrace diversity and inclusivity, fostering an environment where your unique perspective and skills are valued, and where continuous improvement is encouraged. Join us in our journey to reshape the future of healthcare and make a positive impact on the world.