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Job Title: Regulatory Affairs Specialist II
Company Name: Johnson & Johnson
Location: West Chester, PA United States
Position Type: Full Time
Post Date: 04/30/2022
Expire Date: 07/13/2022
Job Categories: Accounting/Auditing, Advertising/Marketing/Public Relations, Biotechnology and Pharmaceutical, Employment Placement Agencies, Finance/Economics, Government and Policy, Healthcare, Practitioner and Technician, Human Resources, Information Technology, Manufacturing and Production, Sales, Sports and Recreation, Research & Development, Medical, Writing/Authoring, Energy / Utilities
Job Description
Regulatory Affairs Specialist II

DePuy Synthes., a division of Johnson & Johnson's Family of Companies is recruiting for a Regulatory Affairs Specialist II in multiple locations.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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 Regulatory Affairs Specialist II is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Synthes Trauma line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA and European MDR) or internal regulatory assessment documentation. The Regulatory Specialist II is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes Trauma products for compliance to FDA regulations, European MDR requirements and company policies and procedures.

 

Duties and 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

 

 

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 (for example, provides Regulatory input into product recall strategies).
  • 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.

 

 

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, 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

Qualifications:

  • Bachelors, Masters, or equivalent is preferred
  • 2+ years of regulatory affairs or related/equivalent experience, including relevant experience with 510(k) submissions and CE marking
  • Demonstrated track record in: Submission of licenses and authorizations for new medical device products is required
    • Knowledge of US Regulations and EU MDR is required
    • International registrations and technical file preparation is required
    • Execution of regulatory strategies that align with business deliverables is required
  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function
  • Ability to work well under deadlines and pressure.
  • Excellent written and communication skills, fluency in English.
  • Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making.
  • Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player

 

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

 

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.


Primary Location
United States-Pennsylvania-West Chester-1301 Goshen Parkway
Organization
Medical Device Business Services, Inc (6029)
Job Function
Regulatory Affairs
Requisition ID
2206034149W
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Contact Information
Company Name: Johnson & Johnson
Website:https://jobs.jnj.com/jobs/2206034149W?lang=en-us&src=HBCUConnect
Company Description:

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