BD (Becton, Dickinson and Company) Regulatory Affairs International Manager in Warwick, Rhode Island
BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.
Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.
The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.
This position is responsible for the development of the International Regulatory Affairs function through the recruiting, hiring, supervision, and development of International regulatory affairs personnel in the support of BDI Surgery product development and overall business objectives.
Recruit, manage, develop and mentor International regulatory professionals.
Prepare and manage annual budgets.
Utilize technical regulatory skills to propose strategies on complex issues.
Provide regulatory input to product lifecycle planning.
Working with regulatory associates, determine International submission and approval requirements.
Assist in regulatory due diligence and acquisition transfer activities.
Through regulatory staff provide strategic input and technical guidance on International regulatory requirements to development teams.
Manage and execute pre-approval compliance activities.
Assess the acceptability of quality, preclinical and clinical documentation for International submission filing.
Negotiate and interact with International regulatory authorities during the development and review process to ensure submission approval.
Monitor impact of changing regulations on International submission strategies and update internal stakeholders.
Prepare International regulatory submissions.
Monitor and submit applicable reports and responses to International regulatory authorities.
Provide regulatory support for and appropriate follow-up to International regulatory agency inspections and audits.
Develop, implement and manage appropriate SOPs and systems to track and manage International product-associated events.
Submit/review change controls to determine the level of change and consequent International submission requirements.
Provide training for stakeholders on current and new International regulatory requirements to ensure company-wide compliance.
Communicate International regulatory agency/industry positions to internal stakeholders.
Strategize with and advise internal stakeholders on International regulatory issues.
Conduct technical meetings with International regulatory advisory committees and government agencies as necessary.
Accompany International regulatory agency 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 required.
Prepare and take leadership in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations.
Special projects as assigned.
Bachelor’s degree in Science, Engineering or other medical or technical degree required.
Minimum of 5-8 years of demonstrated extensive working knowledge and experience with the requirements for medical device registration/licensing in the EU(EU MDD/MDR), Japan, Canada, Australia, Latin America, China, Rest of Asia and other international geographies.
Knowledge of medical products quality system principles and practices.
Prior experience supervising regulatory affairs professionals required.
Ability to work independently with confidence, resolve conflicts, and negotiate with a “win-win” approach.
Experience working with international businesses or cultures.
Good oral and written communication skills – ability to work on cross-functional teams.
Ability to travel approximately 20% of time.
Master’s degree preferred.
BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.
Industry Standard/Category: Medical Device / Regulatory Affairs
Career Level: management
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 100 Crossings Boulevard
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.