Regulatory Affairs Manager

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Summary: 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/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. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The RA manager serves as the company’s regulatory expert and is responsible for communications with FDA and international regulatory agencies. 

 You will:

• 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 
• 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
• Provide Regulatory Affairs support during internal and external audits 
• Responsible for communicating business related issues or opportunities to next management level 
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. 
• 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 
• Responsible for ensuring 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 is highly preferred
• 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

Other:

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

#LI-AM2

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits