DePuy Synthes is recruiting for a RA Manager, CNV, located in either Miami Lakes, FL or Irvine, CA.
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.
The purpose of this role is to administer the day-to-day Regulatory Affairs operations by directly or indirectly managing teams of employees or managing third-party vendors. In addition, this job exhibits a high degree of independent judgment and execute on plans that directly impact the operational results of business units.
POSITION DUTIES & RESPONSIBILITIES:
- Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies.
- Develop world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
- Provides guidance to project team members regarding regulatory and compliance issues by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
- Oversees the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurovascular products, including Class III devices.
- Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new devices and regulatory support of marketed devices.
- Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
- Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
- Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- This role leverages scientific and technical understanding of medical devices to serve as a resource and strategic partner for development and planning throughout the product lifecycle in applicable markets.
- Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
- Advises and challenges others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo.
- Excellent written, verbal communication and presentation skills are required.
- Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (US and EU) is required.
- The ability to partner and influence key stakeholders on NPD and Lifecycle teams is required.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
- The ability to cultivate external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners is required.
- The ability and experience to anticipate regulatory changes in key markets to maximize patient access to innovative technologies is highly desired.
- A minimum of a Bachelor’s Degree
- Minimum 8 years working in a highly regulated environment
- Minimum 5 years Regulatory Affairs experience
- Practical experience in a medical device Regulatory Environment
- Preparing submissions for Class II and III medical devices in the US and EU
- This position can be located in Irvine, CA or Miami FL and may require some travel
United States-Florida-MiamiOther Locations
North America-United States-California-IrvineOrganization
Depuy Orthopaedics. Inc. (6029)Job Function
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