Regulatory Affairs Project Manager

deka; Richmond (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

DEKA Research & Development is seeking a Regulatory Affairs Project Manager to shape regulatory strategies for FDA clearance/approval and international approvals including CE Marking. You will work closely with development teams and customers to drive 510(k)s, PMAs, IDEs and technical files, while guiding R&D on regulatory paths across the product life cycle.

The role requires strong communication, 5+ years in regulated life sciences, and experience with FDA processes such as Q-submissions and

Qualifications

• BS in a technically related field is required.
• 5+ years in medical device, drug, or biologic regulatory role with successful approvals/clearances.
• Experience with FDA interactions including premarket submissions, IDEs, Q-submissions and meetings.
• Strong written and verbal communication skills are essential.
• Ability to balance multiple priorities in a fast-paced environment.
• Knowledge of FDA processes incl. eSTAR, registration/listing, UDI, labeling, post-market actions.
• Familiarity with Medical Device Quality Regulations (QMSRs, ISO 13485, MDSAP).
• Ability to expand regulatory capabilities within the organization.
• Drug/biologic/combination product approvals a plus.
• RAC certification a plus.

Responsibilities

• Collaborate with customers and development teams to define and execute regulatory programs (510(k)s, PMAs, IDEs, Technical Files, and international dossiers).
• Provide leadership to R&D on regulatory strategies across product life cycles.
• Mentor staff and cross-functional partners on regulatory strategies and tactics.
• Lead FDA interactions including meetings, teleconferences, and submissions.
• Support design of clinical trials and obtain/maintain FDA and IRB/ethics approvals as needed.
• Improve internal regulatory processes to increase efficiency and time-to-market while maintaining compliance.

Skills

Regulatory strategy

FDA interactions

Regulatory submissions

Leadership

Communication

Regulatory affairs

Project management

Quality Regulations

UDI

MDR

QMSR / ISO 13485

RAC certification

Education

Bachelor's degree in a technical field

Tools

eSTAR submission tool

FDA portal

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.