Manager, Regulatory Affairs (Special Projects) - Medical Device Business Services, Inc. - 2406174118WDescriptionJohnson and Johnson Medical Device Companies is recruiting for a Regulatory Affairs Manager, Special Projects . The preferred location for this role is Raynham, MA however other remote options within the US will be considered on a case by case basis . Please note: a preferred candidate has already been identified however all applications will still be considered.About Johnson & JohnsonAt 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/.The Regulatory Affairs Manager, Special Projects will lead a team responsible for the development of global regulatory strategies and timelines for Global Orthopedics Regulatory Initiatives and Supply Chain projects supported by Special Projects RA. The team works through cross-functional teams to optimize time to market while ensuring all relevant regulatory requirements are met. The selected candidate will lead their Special Projects team in conversations with global Regulatory Affairs team members to define the path to market for the associated product changes as required.Key Responsibilities:
Defines the strategic regulatory direction for life cycle management projects with a significant dedicated budget
Partners with cross functional leaders to develop and implement strategies for optimized project execution and time to market
Exercises highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects; and is responsible for regulatory aspects of product lifecycle management
Responsible for ensuring aligned and coordinated contact and communication with global and regional/local regulatory agencies
Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements
Assures timely regulatory clearances for key product changes in all key markets
Identify and assess external innovation opportunities connected to the area of responsibility– both screening & technical due diligence (or designate team member)
The base pay range for this position is $115,000 to $180,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.https://www.careers.jnj.com/employee-benefitsQualificationsQualifications
Minimum of a Bachelor’s Degree within a technical related discipline is required ; M.S., M.E., PhD or MD strongly preferred .
Minimum 8 years relevant regulated industry experience is required .
Demonstrated track record of delivering on global regulatory strategies that align with business deliverables is required .
Experience working with professional and trade associations is a plus .
Previous experience with medical devices is required .
10- 25% Travel
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.This job posting is anticipated to close on 3/11/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Primary Location NA-US-Massachusetts-RaynhamOther Locations NA-United StatesOrganization Depuy (Ireland) Limited (7386)Job Function Regulatory AffairsReq ID: 2406174118W
