Sr. Regulatory Affairs Program Lead
Location:
Raynham , Massachusetts
Posted:
February 08, 2017
Reference:
8964170203-en-us

DePuy Synthes is recruiting for a Senior RA Program Lead, located in Raynham, MA.

 

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.  For more information, visit www.depuysynthes.com

 

The Senior RA Program Lead serves as a consultant and technical expert on Regulatory Affairs matters and 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 little to no supervision the individual provides assistance in preparation and submission of global regulatory documents.  He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.  The Senior RA Program Lead helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.

 

:

  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
  • Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
  • Defines data and information needed for regulatory approvals.
  • Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
  • Provide Regulatory Affairs support during internal and external audits.
  • Plans schedules for regulatory deliverables on a project and monitors project through completion.
  • Assists in the development of best practices for Regulatory Affairs processes.
  • Represents Regulatory Affairs on cross-functional project teams.
  • Partners with other functions to define and obtain data to assist with regulatory submissions.
 

:

  • Excellent written, verbal communication and presentation skills
  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
  • Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives.  Takes accountability for the achievement of business goals and objectives.
  • Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (especially EU).
  • Ability to partner and influence key stakeholders on NPD and Lifecycle teams.
  • Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear).          
  • Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.
  • Knowledgeable in US, EU and International Regulations

:

  • 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 regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
  • Lead by leveraging diverse perspectives and backgrounds 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
  • A minimum of a Bachelor’s degree from accredited college or university is required.  A degree focused in science, biomedical engineering, medical/ scientific writing, public health administration preferred.
  • 6 years working in regulated healthcare industry is required.  Medical device experience preferred.   
  • Experience in the preparation, and submission of US Regulatory files (510(k)s, PMAs) and/or European technical files and design dossiers is required.
  • Knowledge of US, EU and International Regulations required.  Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.
  • Experience with Medical Device Navigation Software and Instruments and/or Medical Device Software is preferred.
  • This position is located in Raynham, MA and may require approximately 10% travel.


Primary Location
United States-Massachusetts-Raynham
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Regulatory Affairs

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