Sr R&D Technician
Company: BD (Becton, Dickinson and Company)
Posted on: June 12, 2021
Job Description Summary
The Director Regulatory Affairs position reports directly to the
BDI Surgery VP Regulatory Affairs. This position is responsible for
the development and leadership of the regulatory affairs function
in the Advanced Repair and Reconstruction platform. Through
recruiting, hiring, supervision, and development of regulatory
affairs personnel in support of key product development programs
and overall business objectives, the Director assures compliance
with applicable regulations for all pre-market and post-market
product support activities.
The Director Regulatory Affairs must be a strategic thought
partner to the platform lead supporting the growth agenda in key
strategic initiatives. S/he must collaborate effectively with
R&D, Marketing, Clinical/Medical Affairs, Quality and
other functional areas to provide his/her regulatory expertise
to effectively develop regulatory strategies that successfully lead
products through the FDA clearance/ approval process, as well as
other global regulatory agencies.
- Recruit, manage, develop and mentor regulatory
- Prepare and manage annual budgets.
- Utilize technical regulatory skills to propose strategies on
- Provide regulatory input to product lifecycle planning.
- Working with regulatory associates, determine submission and
- Assist in regulatory due diligence and acquisition transfer
- Through regulatory staff provide strategic input and technical
guidance on regulatory requirements to development teams.
- Manage and execute pre-approval compliance activities.
- Assess the acceptability of quality, preclinical and clinical
documentation for submission filing.
- Negotiate and interact with regulatory authorities during the
development and review process to ensure submission approval. Build
positive relationships with reviewers.
- Monitor impact of changing regulations on submission strategies
and update internal stakeholders.
- Monitor and submit applicable reports and responses to
- Maintain annual licenses, registrations, listings and patent
- Ensure compliance with product post-marketing approval
- Review and approve labeling to ensure compliance with
regulations and company policy.
- Review and approve advertising and promotional items to ensure
- Assess external communications relative to regulations.
- Review publicly disseminated information to minimize regulatory
exposure, review product claims and preserve confidentiality of
applicable product information.
- Review and approve required reports, supplemental submissions
and other post-marketing commitments to update and maintain product
approvals and registrations.
- Provide regulatory input for and appropriate follow-up to
inspections and audits.
- Develop, implement and manage appropriate SOPs and systems to
track and manage product-associated events.
- Submit/review change controls to determine the level of change
and consequent submission requirements.
- Provide regulatory input for product recalls and recall
- Provide training for stakeholders on current and new regulatory
requirements to ensure company-wide compliance.
- Communicate regulatory agency/industry positions to internal
- Strategize with and advise internal stakeholders on regulatory
issues and requirements.
- Conduct technical meetings with regulatory advisory committees
and government agencies.
- Accompany inspection team(s) as required.
- Support and lead assigned improvement activities.
- Notify, consult or brief legal counsel when appropriate.
- Function as authorized delegate for function head when
- Prepare and take leadership in professional associations,
industry/trade groups (local/regional/international) and
appropriate standards organizations.
- Required - Bachelor of Science degree in a technical discipline
(e.g., biology, chemistry or engineering)
- Advanced degree (MS,PhD, etc) preferred
- RAPS Regulatory Affairs Certification (RAC) preferred
- Broad knowledge of materials and manufacturing processes,
particularly concerning resorbable technologies and HCT/P
- Extensive knowledge and experience in designing global
regulatory strategies and ensuring timely submission of high
quality documents for medical device product registrations.
Regulatory strategies may include clinical strategies for products
requiring clinical data for regulatory approval or clearance.
- Knowledge of and experience (8-10 years) with regulatory
submission for complex US medical devices ( pre-submissions, RFDs,
IDEs, 510(k)s, PMAs) with particular focus on PMA submissions.
- Significant experience gaining regulatory approvals for medical
devices outside of the United States.
- Experienced in meeting with, making presentations to, and
negotiating with regulators.
- Working experience in medical products design and manufacturing
quality system principles and practices.
- Ability to work independently with confidence, resolve
conflicts, and negotiate with a "win-win" approach.
- A proven track record of recruiting, developing, and retaining
a high performance team.
- Past success operating in a large, matrix-managed
- Solid skill in written and oral communications. Positive energy
and enthusiasm to work in a multi-task environment.
Remote or USA RI - Warwick
Primary Work Location
USA RI - Warwick
Keywords: BD (Becton, Dickinson and Company), Tempe , Sr R&D Technician, Other , Tempe, Arizona
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