Regulatory Affairs Project Manager

DEKA Research & Development

Manchester, NHJobNo compensation foundTracked 1mo agoSeen in employer's feed 3 days ago

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At a glance

Compensation

No compensation found

Location

Manchester, NH

Work Authorization

Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

DEKA Research & Development is hiring a Regulatory Affairs Project Manager. DEKA Research & Development is seeking a Regulatory Affairs Project Manager to join their medical device research and development environment. This role involves formulating and executing regulatory strategies to achieve FDA approval or clearance, as well as international approvals like CE Marking. The individual will have a significant impact on the success of innovative life science devices developed by DEKA.

Key focus areas include Define and execute regulatory approval and clearance programs, Establish regulatory requirements and lead preparation of submissions, and Provide leadership and guidance to R&D on regulatory strategies.

Successful candidates bring BS In Technically Related Field, 5+ Years Regulatory Experience, and FDA Interaction Experience. Important skills include Formulate Regulatory Strategies, Execute Regulatory Strategies, Define Regulatory Requirements, Prepare 510(k)s, Prepare PMAs, and Prepare IDEs. Preferred (not required): Drug Approvals, Biologic Approvals, and Combination Product Approvals.

Skills & qualifications

RequiredNice to have

Skills

Formulate Regulatory StrategiesExecute Regulatory StrategiesDefine Regulatory RequirementsPrepare 510(K)SPrepare PMAsPrepare IDEsPrepare Technical FilesPrepare International DossiersLead FDA InteractionsParticipate in Clinical Trials DesignConduct Clinical TrialsImprove Internal Regulatory ProcessesCommunicationBalance PrioritieseSTAR Submission ToolEstablishment Registration and ListingUDIProduct LabelingPost-Market ReportingMDR'sField Action ReportingMedical Device Quality RegulationsQuality Management Systems RegulationsISO 13485MDSAPExpanding Regulatory Organization CapabilitiesDrug ApprovalsBiologic ApprovalsCombination Product Approvals

Qualifications

BS in a Technically Related Field5+ Years Medical Device Regulatory Role ExperienceExperience in Direct FDA InteractionsRAC Certification

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:

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.

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