BD (Becton, Dickinson and Company) Associate / Regulatory Affairs Specialist 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.
The position of Associate / Regulatory Affairs Specialist Specialist will be responsible to provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in both the U.S. and global regions. Provide regulatory support to marketed products and ensure company’s regulatory compliance status.
Prepare and submit applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k)’s, IDE’s, PMA’s, PMA supplemental applications)
Support in determination of the appropriate regulatory submission requirements and strategies for new or modified products. Prepare required documentation as needed (e.g., No 510(k) Rationales, international change notifications).
Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and respond to any questions posed by these departments or the FDA.
Prepare application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTED, International Dossier).
Assist Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
Assist in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
Represent regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
Assist in development of new product instructions for use/promotional material. Review product labeling for compliance with medical device regulations and Division/Corporate Policies.
Provide marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Support due diligence and business integration activities as assigned.
Support the development and implementation of BDI's regulatory processes, procedures, and standards as assigned.
Special projects as assigned.
Bachelors of Science required, with emphasis on life science or engineering.
Associate Regulatory Affairs Specialist: Minimum of 0-3 years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers).
Regulatory Affairs Specialist: Minimum of three years knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s, 510(k)’s, CE mark technical files and design dossiers).
Previous experience in supporting regulatory projects and R&D/Quality teams.
Solid knowledge in FDA, EU regulations for medical device.
Good oral and written communications skills and ability to work on cross-functional teams.
Working knowledge of statistics and electronic documentation and information systems.
Ability to travel approximately 10% of time.
Professional certifications preferred.
Advanced Degrees preferred.
*Determination of level will be based upon years of experience & demonstrated knowledge/skills.
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: entry level
Division Name: Warwick, RI / BDI Surgery
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.