BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist in Warwick, Rhode Island

Job ID: 2018-12145

Career Level: experienced

Division: BDI Surgery

Relocation: No

Location: Warwick,Rhode Island,United States

Summary of Position with General Responsibilities:

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

compliance status.

Essential job Functions:

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

Policies.

9. Provide marketed product regulatory support for change management activities, product

registrations, and business improvement activities.

Released

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.

Basic Qualifications:

B.S. or equivalent with emphasis on Life Sciences. Professional certifications and advanced

degree preferred.

- 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

dossiers).

- 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.

Additional Desirable Qualifications Skills and Knowledge:

Key Relationships

Internal Relationships:

Quality Assurance

Research and Development

Manufacturing Operations

Sales

Marketing

Finance

External Relationships:

Corporate Regulatory, Medical, and Legal

Bard International Business Centers RA

Food and Drug Administration

Notified Bodies

Competent Authorities

Consultants

Training Required

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

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status