Regulatory Affairs Specialist II (DePuy Synthes) - Medical Device Business Services, Inc. - 2406170309WDescriptionDePuy Synthes, part of the Johnson & Johnson family of companies, is current recruiting for a Regulatory Affairs Specialist II role to support our Sports Medicine business. The preferred location is within a commutable distance of Raynham, MA but candidates may also reside within a commutable distance of West Chester, PA . This role will work a Flex/Hybrid schedule with 3 days in office per week.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 Specialist II 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. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The RA Associate II helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role assists in the development of best practices for Regulatory Affairs processes.Primary Responsibilities :
Ensures compliance with regulatory agency regulations and interpretations.
Prepares responses to regulatory agencies' questions and other correspondence.
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Provides solutions to a variety of problems of moderate scope and complexity.
Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance.
Provides regulatory guidance to product development teams and responds to product information requests.
Provide Regulatory Affairs support during internal and external audits.
Assists in the development of best practices for Regulatory Affairs processes.
Represents Regulatory Affairs on cross-functional project teams.
QualificationsMinimum Requirements:
Minimum of a Bachelor's Degree is required ; Advanced Degree preferred .
At least 2-4 years of regulatory affairs or related experience , preferably within the MedTech and/or Pharma sector or other highly regulated industry.
Excellent written and oral communication skills.
Excellent organizational skills preferred.
Ability to handle multiple tasks and be detail oriented.
Ability to apply risk-benefit analysis techniques.
RAC certification for Medical Devices preferred .
Up to 10% expected travel for domestic and/or international.
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 .This job posting is anticipated to close on 3/20/2024. 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-US-Pennsylvania-West ChesterOrganization Medical Device Business Services, Inc (6029)Job Function Regulatory AffairsReq ID: 2406170309W
