DEKA Research and Development Corporation

Regulatory Affairs Project Manager

DEKA Research and Development Corporation • $90K — $120K *
Manchester, NH 03103In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted 2 days ago
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BS in a technically related field
  • 5+ years in medical device, drug, or biologic regulatory roles
  • Proven success in product approvals/clearances
  • Experience with FDA interactions and submissions
  • Strong written and verbal communication skills
  • Ability to manage priorities in a fast-paced environment
  • Knowledge of FDA processes and regulations

Responsibilities

  • Collaborate with customers to define regulatory strategies
  • Guide R&D in developing regulatory strategies across product life cycle
  • Mentor regulatory affairs staff and cross-functional partners
  • Lead FDA interactions and submissions
  • Assist with clinical trial design and regulatory approvals
  • Enhance internal regulatory processes for efficiency
  • Ensure compliance while reducing time to market

Benefits

  • Dynamic and innovative work environment
  • Significant impact on product success
  • Mentorship opportunities
  • Engagement with cross-functional teams
  • Professional development in regulatory affairs
  • Participation in cutting-edge medical device projects
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.
Learn more about DEKA Research and Development Corporation
Size
1,000 employees
Industry
Aerospace & Defense
Founded
1982
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at DEKA Research and Development Corporation

More Pharmaceuticals & Biotech Jobs

Find similar Regulatory Affairs Project Manager jobs:

NationwideManchester, NH