Associate Director Global Regulatory Operations Labeling
Franklin Lakes, NJ 07417
Location: Northern New Jersey
Industry: Medical Equipment / Devices
Job Category: Legal - Regulatory / Compliance Law
Contact: Ken Kupersmith
New position created to report to the VP of Regulatory Operations, the Associate Director of Global Labeling will play a lead role in building and refining global labeling processes and capabilities, and provide strategic guidance in the development and maintenance of the regulatory content of global labeling, instructions for use (IFUs and eIFUs) etc., including leading cross-functional labeling team workstream for EU Medical Device Regulations (MDR)/In-Vitro Diagnostics Regulations (IVDR) program.
1.Lead Regulatory labeling function in Regulatory Affairs, and build new, scalable capability and processes to support growth as a commercial organization.
2.In collaboration with Global Business Unit Regulatory Leads, create, revise and maintain product labeling for products.
3.Lead and/or provide support in authoring labeling for each region that aligns with company core labeling requirements for health authorities,
4.Provide strategic guidance to Core Labeling Teams regarding current and new labeling regulations, competitor labeling, and labeling trends.
5.Lead and/or assist with the preparation of responses to labeling related queries from health authorities.
6.Monitor regulatory environment for new or revised legislation, regulations and guidance documents for health authorities related to product labeling, and assess and communicate impact.
7.Develop or revise procedures as needed
8.Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures where appropriate.
9.Assess and provide recommendations of best practices between business units and drive to standardization of processes where possible.
1.Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
2.Sound working knowledge of the Global regulatory environment
3.Experience and knowledge of PC/database skills
4.Experience and knowledge of document management systems
5.Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives
6.Proven ability to resolve conflict (striving for win-win outcomes)
7.Proven ability to deliver tough messages in a professional manner
8.Bachelor degree in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
9.Working knowledge of Medical Device and IVD development and approval process and life cycle maintenance
10.Minimum of 10 years of professional experience of relevant medical device with 5+ years of relevant regulatory affairs labeling experience.
Competitive Base Salary
Relocation Assistance Available For Ideal Candidate
Interview Travel Reimbursed
10+ to 15 years of experience
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Visa Candidates Not Considered