The Opportunity:

We are recruiting an experienced Regulatory Affairs Specialist who has worked in a healthtech/pharma company or on healthtech products, on both the EU and US regulatory frameworks. As this is a new department, we are looking for someone willing to build processes and practices from scratch, to be independent and proactive, yet also flexible to adapt to strategic product changes. The role can be done entirely remote, but some international travel is expected. You can also choose to work part time at one of our offices in Budapest or Cambridge, MA.

The position is flexible and will be further developed and adapted to fit the right candidate, therefore, please apply even if you do not fit all the requirements and/or are not sure you can do all the tasks described below. 

The Role:

As the Regulatory Affairs Specialist you will be ideally responsible for managing the FDA and MDR/IVDR compliance framework and processes, while also overseeing our quality management procedures. Your role will involve ensuring that our organization complies with all relevant medical regulatory requirements and standards.

You will work closely with the Head of Legal and Regulatory, with our Chief Scientific Officers and with our advisors on medical affairs and regulatory. You will report to the Head of Legal and Regulatory.

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Key Responsibilities:

Compliance Management

• Develop and maintain a comprehensive understanding of FDA and MDR/IVDR regulations applicable to our products. 
• Maintain knowledge of current FDA, EMA and international regulations/guidelines/policies related to medical devices as applicable to Genomate’s products and services.
• Lead the company's efforts to obtain and maintain FDA approvals and CE marks for our products. Prepares regulatory submissions for new product approvals including 510(k) premarket notifications, EU MDR and IVDR.
• Ensure all regulatory submissions and documentation are accurate, complete, and submitted in a timely manner.
• Stay updated on regulatory changes and provide guidance to cross-functional teams to ensure ongoing compliance.
• Collaborate with internal teams to ensure all products meet regulatory requirements throughout the development lifecycle.
• Independently manage project scope, timelines, strategy, and communication.
• Articulate potential risks, timelines, and updates clearly and efficiently.
• Cultivate strong stakeholder relationships and serve as the primary point of contact on projects. Communicates directly with regulatory consultants and advisors.
• Evaluate design changes to products to determine impact to submissions and potential need for additional submissions.
• Provide interpretive analyses of standards, regulatory guidance documents, regulations, proceedings, or directives that impact Genomate’s products, operations and development programs.
• Research sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
• Represent regulatory on product development teams, developing and executing regulatory plans, and providing regulatory impact information for project options. 
• Assess and respond to deficiencies issued by health authorities in response to new registrations, variations, renewals, etc.
• Conduct regulatory intelligence to identify country specific regulations and requirements for Genomate’s products.
• Provide regulatory expertise and guidance on regulations and requirements.

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Quality Management

• Establish, implement, and manage a quality management system (QMS) that aligns with ISO 13485 and other relevant standards.
• Conduct internal audits, quality reviews, and risk assessments to identify and address areas for improvement.
• Drive a culture of quality throughout the organization, promoting best practices and continuous improvement.
• Work closely with teams to resolve quality issues and implement corrective and preventive actions).
• Oversee supplier quality management, including vendor audits and performance assessments.

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Requirements:

• Bachelor's degree in a relevant field (e.g., Law, Management, Affairs, Biotechnology, Life Sciences) is required; advanced degree preferred.
• Minimum of 2 years of experience in medical device regulatory affairs and quality management. Successful FDA and EU-notified bodies submission experiences is preferred. 
• In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820) and EU MDR/IVDR regulations.
• Familiarity with ISO 13485 and other relevant quality standards.
• Experience working in the medical software and biotechnology industries is highly desirable.
• Working understanding of US, EU, international regulations on medical devices.
• Prior interaction or exposure with other key regulatory authorities in other countries (e.g., Latin America, India etc.) would be an advantage.

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Required Soft Skills:

• Strong project management skills, including the ability to prioritize tasks and meet deadlines.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
• Strong communications skills, oral, written and electronic.
• Strong attention to detail and the ability to handle multiple competing projects effectively and work independently with international oversight.

Benefits:

• Possibility to work fully remote from any location.
• Flexible role, with resources available for personal and professional development. 
• Possibility for growth in a fast-paced, high potential international company. 
• Compensation according to experience.

Contact: 

Orsolya PÉTER, Director of Human Resources 

orsolya.peter@genomate.health 

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Due to the expected large number of applications, we will contact only shortlisted candidates.