Job Description Summary

Job Description

Job Summary

This position is responsible for implementing BD's regulatory policies and procedures related to multiple projects within the business unit. The Regulatory Affairs Manager will be responsible for managing other Regulatory associates and directly supporting projects to bring new and modified medical devices to market and ensure ongoing compliance. You and your direct reports will participate in cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, lead interactions with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. This role interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.

The ideal candidate will have excellent organizational, problem solving and analytical skills: able to manage multiple tasks and meet timeline commitments. Having excellent written and verbal communication skills; can communicate across cultures; collaborate with a cross-functional team; effectively interact with technical and legal associates; and negotiate with Regulators is pivotal for success in this opportunity. Having the ability to work in a team-oriented, fast-paced environment; develop, mentor, and coach regulatory team members and being effective in complex projects with ambiguity and rapid change is key!

Job 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

Minimum Requirements

• 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 Experience/Skills

• 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

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

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