Regulatory Affairs Manager

Are you ready to join Connecticut Innovation’s vibrant community of innovators? Connecticut Innovations (“CI”) is Connecticut’s strategic venture capital arm, and we are passionate about serving our portfolio of 220 companies across various industries, with strengths in life sciences, technology, and climate tech.

Come join one of our quickly growing portfolio companies, Home - Perosphere Technologies!

Perosphere Technologies is hiring a Regulatory Affairs Manager to join the team based in Danbury, CT! This will be an onsite role, 5 days a week.

About Perosphere Technologies

Perosphere is an emerging medical device company which designs, develops and manufactures a diagnostic medical device with addresses an unmet need in a critical medical market. The company’s technology provides an innovative approach to management of critical medical conditions related to hemostasis, i.e., blood coagulation and therapeutic anticoagulation. The Senior Quality Engineeer will play a central and key role in the company’s global market penetration by leading ambitious programs for both company and device certifications and registrations in the USA and on a global basis. The incumbent is a key member of middle management and works side-by-side with the Executive Leadership Team to plan, execute and deliver on these strategic objectives.

Regulatory Affairs Manager

The Regulatory Affairs Manager coordinates and facilitates global regulatory registrations outside the USA (OUS) and manages and prepares US regulatory submissions. As the regulatory member of development teams, this manager plans the registration strategy for new products or product improvements which are aligned with the sales and marketing plan, on a country and regional basis. OUS product registration is a primary responsibility in the target regions/countries and preparation of the FDA pre-market 510(k) filings.

The RA Manager also provides advice and strategic planning with regards to compliance issues related to the FDA and OUS regulatory requirements as stated in the relevant quality system documents of the FDA Code of Federal Regulations, EU In Vitro Device Directive, EU In Vitro Device Regulation, ISO and CE Mark requirements. This includes Vigilance and Medical Device Reporting. In the professional capacity, the RA manager:

What You'll Do:

• 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.

Education and Experience:

• Bachelor of Science in Chemistry, Biology, Medical Technology, or related area from an accredited four-year college or university.
• Advanced degree MS is a plus in this position but not required
• 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

Knowledge Skills & Abilities:

• Experience with US FDA filings and updates related to premarket approval, e.g., 510(k), related CLIA categorization submissions and follow up FDA correspondance is required.
• Must have a high level of multi-task management and be able to use program management tools such as MS Excel. Knowledge of MS Project is a plus.
• 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

Why Work at Perosphere Technologies?

Purpose-Driven Work: Help shape the standard of care for millions of patients on DOACs.

Market Opportunity: ~$1B addressable market across U.S. and EU hospital systems.

Innovation & Impact: Be at the forefront of hospital-based precision diagnostics.

Perosphere Technologies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.