REGULATORY AFFAIRS SPECIALIST II (DEPUY SYNTHES) - MEDICAL DEVICE BUSINESS SERVICES, INC.

DePuy Synthes, Inc.
is currently recruiting for a Regulatory Affairs Specialist II to support Life Cycle Management and New Product Development.
This role will work a Hybrid/Flex schedule with 3 days in office each week, located in Raynham, MA or West Chester, PA.
About Johnson & Johnson 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.
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The Regulatory Affairs Specialist II will execute regulatory activities to support currently marketed devices and new product development in the DePuy Synthes Sports Medicine line of products.
This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business.
Key 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.
Qualifications Qualifications.
· Minimum of a Bachelor’s Degree required, Advanced Degree strongly preferred.
· At least 2+ years of Regulatory Affairs or related/equivalent experience · Experience with US FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) Preferred.
· Experience in orthopedics and orthopedic device regulatory requirements.
· Experience with the preparation and completion of US, EU, or international regulatory submissions.
· Experience and understanding of product development process and design controls.
· Demonstrated global perspective, cross-functional collaboration and partnership skills.
· Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.).
· Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part.
· Excellent written and oral communication skills · Ability to balance multiple tasks with attention to detail Other.
This position is located in either Raynham, MA or West Chester, PA and may require up to 10% travel, 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.
areers.
nj.
om.
This job posting is anticipated to close on .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.