Regulatory Affairs Specialist

About Fuze Health
At Fuze Health, we put patients first and tirelessly address the most pressing needs in healthcare. We empower millions to digitally connect with care providers, essential health resources and needed treatments – and enable care providers, employers, health plans and life sciences companies to meaningfully enhance quality, outcomes and value. We are dedicated to helping our partners evolve and modernize to meet emerging patient and marketplace needs.

Fuze Health’s foundation is built upon the strategic combination of several proven, technology-powered innovators in the digital health, diagnostics, and pharmacy sectors. Our growing portfolio brings together the capabilities of industry leaders including LetsGetChecked, Truepill, and Alto Pharmacy, to create a distinctive, unified force in healthcare. Together, we have the shared vision, advanced capabilities and talented teams to deliver next-generation solutions that patients and healthcare partners need today and into the future.

LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and Atlanta, LetsGetChecked empowers people to take control of their health and live longer, happier lives.

The Regulatory Affairs Specialist - Fuze Service is a role which involves working cross-functionally with clinical, quality, and engineering teams during the design process, test development, jurisdiction expansion, and product lifecycle. This includes a range of activities related to marketing authorization, submissions, vigilance, adverse event reporting, and clinical evaluation within the In-Vitro Diagnostics/Medical Device environment.

The primary function of this role is to support the management and maintenance of Regulatory Affairs requirements in the global jurisdictions in which LetsGetChecked operates, ensuring smooth and efficient processes. The Quality and Compliance team based in Dublin is responsible for global regulation, managing pre- and post-market regulation for various product classifications across Europe, the USA, and Canada.

Job Description
 

Responsibilities and Duties

• Act as a contributing Regulatory Team member for assigned regulatory projects.
• Creation and review of SOPS, change control forms, CAPA/NCR process.
• Support role to Quality team.
• Support role  in both Internal and External Audits, particularly ISO 13485:2016.
• Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims, IFUs, and associated supporting documentation
• Reviewing product claims in social media and other marketing material
• Contribute to ensuring regulatory requirements are met in a planned and timely manner to avoid delays in approvals.
• Support the development and implementation of the Regulatory Strategy.
• Stay updated on US, EU, and other global regulatory guidelines.
• Build and maintain strong relationships with Regulatory Authorities, Consultants, and internal departments.
• Support the preparation of regulatory documents to EU competent authorities and the US FDA including device listings, establishment registrations, adverse event reporting, and substantial changes.
• Assist in the maintenance and compilation of EU IVDR and MDR technical files for in vitro diagnostic sample collection kits (IVD Class A) and Class IIa medical devices.
• Participate in Continuous Improvement Initiatives to enhance department functions.
• Actively participate and employ effective communication practices with internal customers (Supply Chain, Quality, Legal, Clinical, Customer Care).
• Review of Product complaints and liaise with the complaints team on open complaints. Assist in complaint investigation as necessary.
• Support role in validation activities
• Prepare status reports and metrics for assigned projects.
• Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
• Any other duties as assigned by your Manager.

What are we looking for?

• Life sciences degree (BSc or equivalent).
• 2-3 years of regulatory experience in the medical device or IVD industry.
• Experience assisting with the maintenance of EU technical files.
• Hardworking, self-motivated, and with attention to detail.
• Working knowledge of the USA and EU regulatory requirements and procedures.
• Familiarity with MS Office, or equivalent.
• Excellent written and oral communication skills, attention to detail, and the ability to handle multiple projects.
• Preparation of relevant technical, safety, and performance technical documents to support submissions, in collaboration with Technical/Clinical/Labelling experts.
• understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options.
• Compliance with SOPs, Change controls and regulatory best practices.

Additional Information
 

Salary and Benefits

Salary Range: €€45,000-€50,000

Benefits - Fuze Health 

• Health insurance and an Employee Assistance Programme 
• Pension
• Annual Compensation Reviews 
• A referral bonus programme to reward you for helping us hire the best talent
• Internal Opportunities and Careers Clinics to help you progress your career within the company
• Maternity, Paternity, Parental and Wedding leave
• LetsGetChecked has a flexible annual leave policy

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Equal Opportunity Employer

Fuze Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected basis. If you have a disability and require reasonable accommodation during any portion of the application or hiring process, please contact us at [email protected]. 

Fuze Health considers qualified applicants with arrest or conviction records for employment and conducts background checks consistent with applicable law, including the California, Los Angeles County, San Francisco, Philadelphia, and New York City Fair Chance laws. We are an E-Verify participating company.

Use of Automated Decision Tools

Fuze Health recruiters and hiring managers may use automated decision tools to help identify candidates who match the stated job requirements, and to what extent. These tools are designed to help ensure fairness in all aspects of the hiring process by providing recruiters and hiring managers with data-backed insights based on information provided in your resume, including work experience, education, and other skills. Fuze Health does not use automated decision tools to make hiring decisions; hiring decisions always involve human review and input. If you have any questions or would like to request an alternative process, please contact us at [email protected].

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