Regulatory Affairs Manager

About the role

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Raynham, MA; West Chester, PA; Palm Beach Gardens, FL; Synthes, Oberdorf; Zuchwil.

Responsibilities

• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/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 in the development of best practices for Regulatory Affairs processes
• Serves as the company’s regulatory expert and is responsible for communications with FDA and international regulatory agencies
• Represents Regulatory Affairs on cross-functional project teams
• Pairs with other functions to define and obtain data to assist with regulatory submissions
• Might work with International Affiliates directly
• Provides Regulatory Affairs support during internal and external audits
• Communicates business related issues or opportunities to next management level
• Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Requirements

• Bachelor’s degree or equivalent 6 years of related experience
• Experience in the Medical Device industry or medical field
• Demonstrated knowledge of US and EU Medical Device Regulations preferred
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society or advanced degree in Regulatory Affairs, desirable

Qualifications

• Preferred Experience with power devices is highly preferred

Skills

• Other Ability to travel up to 10% may be required both domestic and international

Benefits

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
• Eligible for the following time off benefits: Vacation - 120 hours per calendar year; Sick time - 40 hours per calendar year; Holiday pay, including Floating Holidays - 13 days per calendar year; Work, Personal and Family Time - up to 40 hours per calendar year; Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child; Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year; Caregiver Leave - 80 hours in a 52-week rolling period; 10 days Volunteer Leave - 32 hours per calendar year; Military Spouse Time-Off - 80 hours per calendar year