BD · 1 day ago
Manager, Regulatory Affairs
USA UT - Salt Lake City BAS
Full-time
Onsite
Mid, Senior Level
6+ years expBD is one of the largest global medical technology companies in the world. The Regulatory Affairs Manager will be responsible for implementing BD's regulatory policies and procedures, managing regulatory associates, and supporting projects to bring medical devices to market while ensuring compliance.
Health CareMedical DeviceTechnical Support
Responsibilities
Coordinates RA activities for direct reports
Manages RA responsibilities and functional goals which may consist of FDA and BD required filings and new information dissemination
Makes preliminary determinations regarding the appropriate US and/or International regulatory submission requirements for new or modified products
Reviews and approves documentation Change Requests, labeling artwork changes, recall and FDA inspection assistance, as defined by BD procedures
Facilitates FDA submission activities and creates 510(k) rationales, global submissions and/or rationales
Writes new product submissions, prepares and/or contributes to FDA and required BD reports, and ensures RA department support on new product teams
Keeps knowledge of FDA and/or global requirements current by attending industry, FDA, and corporate seminars, when possible
Acts as alternate liaison for quality system audits and inspections
Will develop global regulatory strategies
Supervises maintenance of US, CE, and international documentation
Involved with the coordination and management of EU MDR technical file audits; and supports other external and internal audits
Qualification
Required
Bachelor's degree in a scientific field
6-8 years' Regulatory Affairs experience in the medical device industry
Experience leading communications with FDA, EU notified bodies, and other regulatory agencies
Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
Experience with product development processes and design controls
Proficient with Microsoft Office tools (including Word, Excel, PowerPoint)
Knowledge of product development and medical device quality system regulations
Preferred
Master's degree in Regulatory Affairs
1+ years' management experience
Regulatory Affairs Professional Society (RAPS) certification
Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase