Senior Regulatory Affairs Specialist.

Job content

DePuy Synthes Companies of Johnson & Johnson is recruiting for a Senior Regulatory Affairs Specialist to support its Power Tools Team. This position can be located at any of the following sites: Oberdorf, Switzerland; Zuchwil, Switzerland; or Palm Beach Gardens, FL.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools, and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. To learn more, visit www.depuysynthes.com.

The Senior Regulatory Affairs Specialist is responsible for regulatory activities to support currently marketed medical devices in the DePuy Synthes line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities and notified bodies to support product changes. The Senior Regulatory Affairs Specialist is also responsible for creating internal regulatory assessment documentation and for the review and/or approval of documentation such as risk files, device labeling, clinical evaluation as well as the product support information used in the promotion and educational material.

Position Duties & 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.
• Reviews product labeling to ensure compliance.
• Provides regulatory guidance to product teams and responds to product information requests.
• Develops and executes global regulatory change strategies and maintains associated product data in the regulatory information management system and approval database.
• Provides 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 such as standards management, REACH and RoHS compliance, and regulatory affairs compliance and business initiatives.
• Participates in on-going career planning, performance, and training programs.
  
  

Functional And Technical Competencies

• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
• Consults with others to understand the benefits, risks, and J&J Credo-based impact associated with decision alternatives before making decisions.
• Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
• Works independently and collaboratively to accomplish shared goals and objectives for the benefits of patients, customers, and other stakeholders.
  
  

Leadership Competencies

• Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
• Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives.
• Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions.
• Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances.
  
  

Qualifications

• Bachelor’s degree from accredited college or university in science, engineering, math, healthcare, public health administration, or law.
• 5+ years of regulatory affairs or related/equivalent experience.
• Relevant experience with global regulatory submissions such as 510(k), CE marking, MDSAP jurisdictions, and submissions in China would be preferable.
• Relevant experience devising regulatory affairs strategy to support product changes would be preferable.
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable.
  
  

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-Florida-Palm Beach Gardens-4500 Riverside Drive

Other Locations

North America-United States-Massachusetts-Raynham, North America-United States-Indiana-Warsaw, North America-United States-Pennsylvania-West Chester, Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil

Organization

Medical Device Business Services, Inc (6029)

Job Function

Regulatory Affairs

Requisition ID

2105981838W