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Connecticut Innovations · 2 days ago

Regulatory Affairs Manager

Connecticut, United States

Full-time

Onsite

Mid, Senior Level

3+ years exp

Connecticut Innovations is Connecticut’s strategic venture capital arm, dedicated to supporting a diverse portfolio of companies. Perosphere Technologies is seeking a Regulatory Affairs Manager to coordinate and facilitate global regulatory registrations and manage US regulatory submissions for their innovative medical device aimed at addressing critical medical conditions related to hemostasis.

BiotechnologyEnergyInformation TechnologyMedia and Entertainment

Hiring Manager

Marina D.

Responsibilities

Works within the Marketing and Sales Strategic Planning to develop an executable strategy including timeline and resources for OUS product registration purposes

Provides a schedule of OUS product registrations based on the marketing & sales strategic plan

Develops the timeline for US-FDA submissions based on the marketing/strategic plan

Prepares initial US FDA filings and updates related to premarket approval, e.g., 510(k), related CLIA categorization submissions and prepares follow-up FDA correspondence relating to these issues as required

Works with technical teams to outline data submission requirements

As part of the Project Team, coordinates the collection of technical data to support product registrations and premarket submissions

Works with the clinical team to schedule clinical evaluations to establish safety and efficacy of products to support the submissions

Assists in the development of protocols for clinical evaluations to meet submission requirements

Provides direction and guidance in the interpretation of the FDA Medical Device Reporting and EU Medical Device Vigilance Reporting related to product incidents and potential adverse events

Drafts appropriate medical device reports, attains internal review and approval and submits to regulatory agencies

Provides the regulatory and compliance oversight for product labeling in compliance with FDA and OUS regulations

Assists in the development of customer technical bulletins

Qualification

Regulatory submissionsFDA 510(k) filingsMedical device regulationsProgram management toolsClinical evaluationsCommunicationDetail orientedMentoring

Required

Bachelor of Science in Chemistry, Biology, Medical Technology, or related area from an accredited four-year college or university

Minimum of 3 to 5 years experience working in a regulatory submissions or compliance capacity in a regulated medical industry, preferably the Medical Devices industry

Experience with US FDA filings and updates related to premarket approval, e.g., 510(k), related CLIA categorization submissions and follow up FDA correspondence is required

Must have a high level of multi-task management and be able to use program management tools such as MS Excel

Detail oriented and ability to document effectively and completely

Excellent communication skills, both written and verbal

Must have the ability to interact with numerous internal and external customers as the 'face of the business' including regulatory agencies

Able to mentor others within the organization regarding regulatory requirements