Regulatory Affairs Manager

Job Overview

We are searching for the best talent to join our De Puy Synthes Orthopaedics team as a Regulatory Affairs Manager.

• This position may be based in Synthes, Oberdorf; Zuchwil or the
• United

States: Raynham, MA; West Chester, PA; Palm Beach Gardens, FL.

The RA manager leads a team to provide independent regulatory guidance to product development teams in strategic planning, pre‑marketing, and related submissions to support optimal timelines for new or modified product launches.

Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.

The RA manager serves as the company’s regulatory expert and is responsible for communications with FDA and international regulatory agencies.

Responsibilities

• Provides independent regulatory guidance to product development teams in strategic planning, pre‑marketing, and related submissions to support optimal timelines for new or modified product launches
• Manages the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
• Defines data and information needed for regulatory approvals
• Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
• Plans schedules for regulatory deliverables on a project and monitors project through completion; leads the development of best practices for Regulatory Affairs processes
• Represents Regulatory Affairs on cross‑functional project teams
• Partners with other functions to define and obtain data to assist with regulatory submissions
• May work with international affiliates directly
• Provides Regulatory Affairs support during internal and external audits
• Communicates business‑related issues or opportunities to next management level
• Follows all company guidelines related to Health, Safety and Environmental practices as applicable
• For those who supervise or manage staff, ensures that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed are available and in good condition
• Ensures personal and company compliance with all federal, state, local and company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications

Required

Bachelor’s degree or equivalent, 6 years of related experience, experience in the medical device industry or medical field.

Preferred

Experience with power devices, demonstrated knowledge of US and EU medical device regulations, RAC certification by the Regulatory Affairs Professional Society or an advanced degree in Regulatory Affairs, ability to travel up to 10% domestically and internationally.

• Preferred Skills
• Business Writing
• Compliance Risk
• Developing Others
• Fact‑Based Decision Making
• Inclusive Leadership
• Industry Analysis
• Innovation
• Leadership
• Legal Support
• Operations Management
• Policy Development
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Strategic Thinking
• Team Management

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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