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Featured Employers
Regulatory Affairs Specialist II
Company: Johnson & Johnson
Location: Raynham, MA
Employment Type: Full Time
Date Posted: 06/12/2021
Expire Date: 08/18/2021
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Finance/Economics, Healthcare, Practitioner and Technician, Sports and Recreation, Medical
Job Description
Regulatory Affairs Specialist II

DePuy Synthes, Inc. is currently recruiting for a Regulatory Affairs Specialist II!


DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

 


The Regulatory Affairs Specialist II will execute regulatory activities to support currently marketed devices in the DePuy Synthes Sports Medicine and Shoulder Reconstruction 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. 

 


Responsibilities
•    Act as RA lead on multi-platform LCM projects with varying complexities
•    Support project teams by defining regulatory requirements to achieve compliance
•    Work with project team to identify and address critical path or road block issues
•    Create robust global regulatory strategies.  Ensure changes are effectively communicated to global partners for registration impact
•    Ensure project plans and deliverables are compliant with appropriate design control procedures and other global regulation requirements as applicable
•    Compiles regulatory submissions, filing amendments and correspondence with US and EU regulatory authorities
•    Support International team with product re-registration
•    Communicate effectively with Management
•    Participates in process improvement and corporate initiatives as appropriate
•    Support various audits as related to LCM projects
•    Maintains knowledge of current applicable regulations and guidance documents
•    Maintains the highest levels of professionalism, ethics and compliance at all times
 


Qualifications

•    A minimum BA/BS Degree is required
•    At least 2 years of regulated medical device industry experience (or related) is required 
•    Knowledge of U.S. FDA and EU MDD & MDR medical device regulations and guidances is required
•    Strong problem-solving skills and the ability to provide efficient escalation of issues to the appropriate accountable part is required
•    Ability to handle multiple tasks and be detail oriented is required
•    Ability to travel up to 10% domestically and/or internationally as needed is required
•    Knowledge of orthopedic implants a plus
•    Familiarity with international regulations and guidance (such as China, Brazil, Japan, etc.) a plus
•    Familiarity with electronic submission preparation a plus
•    Excellent written and oral communication skills

 


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.
 


Primary Location
United States-Massachusetts-Raynham-325 Paramount Drive
Organization
Medical Device Business Services, Inc (6029)
Job Function
Regulatory Affairs
Requisition ID
2105939664W
Contact Information
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