DePuy Synthes is
recruiting for a Senior RA Program Lead, located in Raynham, MA.
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
- Provide Regulatory Affairs support during internal and external
- Plans schedules for regulatory deliverables on a project and
monitors project through completion.
- Assists in the development of best practices for Regulatory
- 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
- 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
- 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
- 6 years
working in regulated healthcare industry is required. Medical device experience preferred.
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.
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.
Depuy Orthopaedics. Inc. (6029)Job Function