Senior Regulatory Affairs Program Lead - MedTech Surgery

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America

Job Description

We are searching for the best talent for a Senior Regulatory Affairs Program Lead. The preferred location for this role is Cincinnati, OH however candidate may also be based within a commutable distance of Raritan, NJ. This role will work a Flex/Hybrid schedule with 3 days per week on-site; there is NO remote option.

Purpose: The Senior Regulatory Affairs Program Lead executes the Regulatory Affairs platform strategy. We support regional and country product registrations, monitor and assess impacts of product specific regulations for new products as well as lifecycle product registrations.

You Will Be Responsible For

• Provide independent regulatory guidance to project teams in strategic planning, marketing, and related submissions to support optimal timelines for global product launches and related regulatory activities.
• Complete the preparation and submission of regulatory information required to obtain global market access, identifying risk and issues, effectively communicating timelines for project completion, and addressing issues that may impact registration status.
• Execute on plans that directly impact the operational results.
• Work closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling Center of Excellence, as well as global Regulatory Affairs affiliates
  
  

Qualifications/Requirements

• Minimum of a Bachelor's degree is required, Advance Degree preferred; Technical/Science discipline highly desired.
• At least 6 years relevant regulated industry experience is required.
• Minimum of 2 years of medical device regulatory experience is required.
• Independent regulatory submission experience with PMA's is required.
• Experience working directly with EU MDR regulations required.
• A demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is preferred.
• Working knowledge and thorough understanding of how global regulations impact product registration is required.
• Strong written & verbal communication and presentation skills is required.
• Collaborative work style in a highly matrixed environment is required.
• The ability to build and sustain productive partnerships across multiple platforms is required.
• The ability to evaluate new regulatory requirements as well as regulatory changes and correctly assess business impact is preferred.
• Plan and execute complex projects through timely completion is required.
• This role will be based in Cincinnati, Ohio or Raritan, NJ and requires up to 10% travel, including international.
  
  

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.

The anticipated base pay range for this position is :

The anticipated base salary range for this role is $105,000 to $169,050.

Additional Description For Pay Transparency

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits