Jobs in the United States

25+ jobs

Save this search

Added 1 min ago
Manager Professional Practice & Development-Ambulatory
AtlantiCare
Atlantic City, NJ
The Professional Practice and Development Manager is responsible for the efficient day-to-day operations of the system-wide Professional Practice and Development team. The PPD Manager…
Added 2 mins ago
Construction Surveillance Engineer Technician
Bristol Alliance of Companies
Key West, FL
The CSET reviews design plans, submittals, and construction schedules; inspects workmanship and materials; and assists in identifying and resolving technical issues in coordination with…
Added 4 mins ago
Engineering Associate 1 - Communication Engineering
CPS Energy
San Antonio, TX
We are engineers, high line workers, power plant managers, accountants, electricians, project coordinators, risk analysts, customer service operators, community representatives, safety and…
Added 4 mins ago
Release Manager
Black Box
United States
…partnering with Network engineering/implementation teams, program/project manager or directly with the…
Added 5 mins ago
WS
Senior Research Facilities Project Manager
Washington State University
Pullman, WA
- $48.11 USD / hour
- The Senior Project Manager serves as the primary liaison between the Office of Research, researchers, facilities professionals, architects, engineers, contractors, and university…
Added 5 mins ago
MS
Engineer Avionics - Long Island City, NY
Military Spouse Jobs & VetJobs
United States
- $72,000 to $118,400 USD / year
The Engineer reports to the Manager of Engineering and plays a key role in developing and implementing in-service modifications, repairs and other solutions aimed at enhancing aircraft…
Added 5 mins ago
Assistant Project Manager II - Jacksonville, FL
Military Spouse Jobs & VetJobs
United States
Assistant Project Manager II: Manages construction project’s assigned scope(s) of work and duties within
Added 15 mins ago
Instructional Systems Designer (ISD) Lead
By Light Professional IT Services LLC
Remote, United States
…contracts. Dignitas specializes in system and software analysis, design, development, testing, fielding, and courseware for Live, Virtual, and Constructive (LVC) training…
Added 15 mins ago
Construction Manager - Saginaw, MI
Metronet
Saginaw, MI
The Construction Manager is the leader of their assigned project(s) and has the ultimate responsibility for the project budget, meeting project timelines, customer expectations, managing…
Added 17 mins ago
Superintendent, Data Centers
Suffolk
Ashburn, VA
Communicate issues, events, performance, and progress daily to the Project Manager
Added 18 mins ago
Electrical Project Manager
Actalent
Knoxville, TN
Job Title: Electrical Project ManagerJob DescriptionAs a Lead Electrical Project Manager, you will be responsible for reviewing electrical engineering packages from internal teams,…
Added 18 mins ago
Professional Project Manager - Mid
Dewberry
UNAVAILABLE, DC · Huntsville, AL
Dewberry is seeking an experienced Professional Project Manager - Mid Level to support a high-profile federal client to include but not limited to construction, design/build, space…
Added 18 mins ago
Professional Project Manager - Senior, Furniture
Dewberry
UNAVAILABLE, DC
Dewberry is seeking an experienced Professional Project Manager - Senior Level, Furniture to support a high-profile federal client.
Added 18 mins ago
Professional Project Manager - Senior
Dewberry
UNAVAILABLE, DC · Huntsville, AL
Dewberry is seeking an experienced Professional Project Manager - Senior Level to support a high-profile federal client.
Added 18 mins ago
Professional Project Manager - Senior Construction
Dewberry
UNAVAILABLE, DC · Huntsville, AL
Dewberry is seeking an experienced Professional Project Manager - Senior Construction to support a high-profile federal client. The position shall support client related projects, including…
Added 21 mins ago
Senior Manager, M&A Integration & Strategy
Bose Corporation, U.S.A
MA
…successful inorganic growth strategy, consequently, the IMO Manager will lead the end-to-end integration of acquisitions and strategic investments, ensuring operational alignment, cultural…
Added 22 mins ago
Business Manager
NextEra Energy
Juno Beach, FL
Performs quantitative and qualitative research, process design and modification, and report development
Added 23 mins ago
Senior Preconstruction Manager
Wharton-Smith
Sanford, FL
…qualified candidates for the position of Senior Preconstruction Manager. We are currently seeking someone who is willing to work in Central,…
Added 23 mins ago
Preconstruction Services Manager
Wharton-Smith
Sanford, FL
The Preconstruction Services Manager is responsible for all preconstruction activities for complex construction projects. This position applies professional engineering principles and…
Added 24 mins ago
Mechanical Engineer I ($10K-$20K Sign-On Bonus)
SSR
Charlotte, NC · Raleigh, NC
Assist with discipline man‑hour budgets; plan work to schedule and report progress, risks, and needed changes to the project manager.
Added 24 mins ago
Staff Substation Physical Engineer - Transmission & Distribution (Mid Atlantic Region)
Burns & McDonnell
Richmond, VA · Baltimore, MD · Washington, DC · Raleigh, NC
…supervision of a licensed professional engineer to develop physical design deliverables for new and modified high-voltage (13kV to 765kV) electrical power substation projects. The Staff…
Added 24 mins ago
Staff Substation P&C Engineer - Transmission & Distribution (Mid Atlantic Region)
Burns & McDonnell
Richmond, VA · Baltimore, MD · Washington, DC · Raleigh, NC
…licensed professional engineer to develop protection and control design deliverables for new and modified high-voltage (13kV to 765kV) electrical power substation projects. The Staff…
Added 25 mins ago
E
Industrial Engineer
Ethos
Calmar, IA
- $90,000 to $110,000 USD / year
Develop detailed plans, drive project performance, and assure timely completion of improvement projects and savings goals
Added 25 mins ago
E
Project Engineering Manager
Ethos
Cumming, GA
- $125,000 to $150,000 USD / year
We are actively hiring a skilled Project Engineering Manager to join our growing team!
Added 25 mins ago
Territory Manager (TX, Sherman)
Charlie Health
Sherman, TX · TX
Design strategies to better support and engage referral partners across different channels

DEKA Research & Development

Regulatory Affairs Project Manager

Manchester, NH, United States

Apply About employer

Applications open in a new tab.

Job details

Experience: Minimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
Posting language: English
Posted: Jul 23, 2026

Original 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:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

Apply About employer

Report this job