Manage regulatory projects to ensure timely introduction of new products subject to medical
device and combination product regulations in U.S. and global regions. Provide technical and
administrative regulatory support to marketed products and ensure company’s regulatory
1. 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)
2. 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).
3. Coordinate review of FDA submissions and test protocols with Corporate Regulatory, Medi cal
and Legal Departments, and respond to any questions posed by these departments or the FDA.
4. Prepare application documentation for international marketing approvals (i.e. CE Mark
Technical files and Dossiers, JSTD, International Dossier).
5. Assist Product Development and Quality Assurance in planning pre-clinical studies and bench
testing that will ultimately be used in regulatory submissions.
6. Assist in the review of proposals for clinical design validations, clinical field trials and
customer preference tests.
7. Represent regulatory affairs on product development teams to provide direction with respect to
regulatory/clinical requirements and strategy.
8. Assist in development of new product instructions for use/promotional material. Review
product labeling for compliance with medical device regulations and Division/Corporate
9. Provide marketed product regulatory support for change management activities, product
registrations, and business improvement activities.
10. Support due diligence and business integration activities as assigned.
11. Support 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
- Knowledge and experience (5+ years) with regulatory requirements for medical devices and /
or combination products (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design
- 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.
Research and Development
Corporate Regulatory, Medical, and Legal
Bard International Business Centers RA
Food and Drug Administration
See Department training matrix – training category program code # 290406
Scope and Impact of Position:
This position will play a key role in the new product evaluation and new product submission
process as well as maintenance of existing product life cycles. Key responsibilities involve
assurance that clinical evaluations and new product submissions are in compliance with
applicable global medical device regulations, and regulatory support of change management