5+ years in a medical device regulatory role with proven success
Experience in direct interactions with the FDA
Strong written and verbal communication skills
Ability to manage multiple priorities in a fast-paced environment
Expert knowledge of FDA processes and tools
Familiarity with medical device quality regulations and standards
Responsibilities
Define and execute regulatory approval strategies for medical devices
Lead preparation of regulatory submissions like 510(k)s and PMAs
Provide leadership on regulatory strategies across product life cycles
Mentor internal teams and regulatory staff on effective practices
Facilitate FDA meetings and documentation submissions
Participate in clinical trial design and regulatory approval processes
Enhance internal regulatory processes to boost efficiency and compliance
Benefits
High visibility role with direct impact on product success
Mentorship opportunities within the regulatory team
Collaborative work environment with R&D and development teams
Chance to shape regulatory practices in innovative projects
Opportunity for professional growth in a dynamic field.
Full Job Description
DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this high visibility role will have a significant and direct impact on the success of the innovative life science devices that DEKA develops. The person in this role will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as international approvals including CE Marking.
How you will make a difference as a Regulatory Project Manager:
Work in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers
Provide leadership and guidance to R&D in developing successful regulatory strategies across the entire product life cycle
Mentor regulatory affairs staff, as well as internal cross-functional partners, on effective regulatory strategies and tactics
Lead FDA interactions including in-person meetings, teleconferences, written submissions and other Agency engagements as needed
Participate in the design and conduct of clinical trials, and assist in obtaining and maintaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance
Skills you will need to be successful:
BS in a technically related field
Minimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
Experience in direct FDA interactions including premarket notifications, IDE's, Q-submissions and participation in face-to-face meetings
Strong written and verbal communication skills
Demonstrated ability to continually balance priorities in a dynamic and fast-paced environment
Expertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR's and Field Action Reporting
Experience in Medical Device Quality Regulations including Quality Management Systems Regulations (QMSRs), ISO 13485, and MDSAP
Demonstrated ability in expanding regulatory organization capabilities
Experience with drug, biologic and combination product approvals a plus
RAC certification a plus
About DEKA Research and Development Corporation
DEKA Research and Development Corporation is a research and development company based in Manchester, New Hampshire. The company was founded in 1982 by Dean Kamen, an inventor and entrepreneur who has over 440 patents to his name. DEKA is known for developing innovative technologies in a variety of fields, including medical devices, robotics, and transportation. Some of the company's most notable inventions include the Segway personal transporter, the iBOT mobility system, and the DEKA Arm prosthetic limb. DEKA has received numerous awards and accolades for its work, including the National Medal of Technology and Innovation in 2000.
