Combination Products, Medical Device, Quality/Risk Management
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all.
The Senior Regulatory Affairs Specialist will manage regulatory projects to ensure timely introduction of new products subject to medical device and combination product regulations in U.S. and global regions. In addition, you will provide technical and administrative regulatory support to marketed products and ensure company’s regulatory compliance status.
Preparing and submitting applications to the FDA for clinical testing and marketing of new/modified medical devices (e.g., 510(k), IDE, PMA, PMA supplemental applications).
Supporting in determination of the appropriate regulatory submission requirements and strategies for new or modified products.
Preparing required documentation as needed (e.g., No 510(k) Rationales, international change notifications).
Coordinating review of FDA submissions and test protocols with Corporate Regulatory, Medical and Legal Departments, and responding to any questions posed by these departments or the FDA.
Preparing application documentation for international marketing approvals (i.e. CE Mark Technical files and Dossiers, JSTD, International Dossier).
Assisting Product Development and Quality Assurance in planning pre-clinical studies and bench testing that will ultimately be used in regulatory submissions.
Assisting in the review of proposals for clinical design validations, clinical field trials and customer preference tests.
Representing regulatory affairs on product development teams to provide direction with respect to regulatory/clinical requirements and strategy.
Assisting in the development of new product instructions for use/promotional material.
Reviewing product labeling for compliance with medical device regulations and Division/Corporate Policies.
Providing marketed product regulatory support for change management activities, product registrations, and business improvement activities.
Supporting due diligence and business integration activities as assigned.
Supporting the development and implementation of Davol and Bard regulatory processes, procedures, and standards as assigned.
B.S. or equivalent with emphasis on Life Sciences. Professional certifications and advanced degree preferred.
3+ year’s professional experience with regulatory requirements for medical devices and/or combination products (IDE, PMA, 510(k), CE mark technical files and design dossiers).
Knowledge, Skills & Abilities
Good oral and written communications skills - analytical thinking and technical writing;
Ability to work on cross-functional teams; ability to manage several parallel deliverables.
Working knowledge of statistics and electronic documentation and information systems.
Ability and desire to travel as needed.
We offer a competitive salary and comprehensive benefits package. For immediate consideration, please apply online at: