Regulatory Affairs Manager F/M

As Regulatory Affairs Manager, you will play a key role in implementing and executing the regulatory strategy for our innovative medical device portfolio, with a strong focus on Software as a Medical Device (SaMD).

Reporting to the VP Regulatory Affairs, you will contribute to obtaining and maintaining regulatory approvals worldwide while ensuring ongoing compliance with applicable regulations. You will work closely with cross-functional teams including Clinical, Quality, R&D, Product and Marketing.

Your main responsibilities

• Implement the regulatory strategy defined by the VP Regulatory Affairs.

• Define and maintain product intended use, indications for use, labeling and related documentation.

• Support the regulatory classification strategy and determine the appropriate regulatory pathways across global markets.

• Lead and contribute to the preparation, submission and maintenance of regulatory dossiers, including FDA and CE Marking activities.

• Review and approve key technical documentation, including:

  • Product specifications and requirements

  • Risk management documentation

  • Verification and validation documentation

  • Product labeling and user documentation

• Assess product and process changes to determine regulatory impact and required regulatory actions.

• Maintain regulatory policies and regulatory requirements tracking.

• Manage and maintain data within regulatory databases such as FDA Device Listing, EUDAMED and ClinicalTrials.gov.

• Monitor changes in the regulatory landscape and assess their impact on the business and product portfolio.

• Act as Deputy PRRC (Person Responsible for Regulatory Compliance) in accordance with MDR 2017/745.

• Act as Deputy Materiovigilance Officer.

Why join us?

• Contribute to innovative AI-powered medical technologies.

• Work on products with direct impact on patient care.

• Join a highly collaborative, international and multidisciplinary environment.

• Play a key role in global regulatory submissions and market access strategies.

Median Technologies is committed to cultural diversity, gender equality and the employment of disabled workers.

Education

• Master's degree or PhD in Biological Sciences, Medical Sciences or a related field.

Experience

• 3-5 years of experience in Regulatory Affairs within Medical Devices, In Vitro Diagnostics (IVD) and/or Software as a Medical Device (SaMD).

• Experience defining intended use, indications for use and product labeling documentation.

• Hands-on experience preparing and submitting regulatory dossiers for:

  • US FDA submissions

  • CE Marking under EU regulations

• Solid understanding of regulatory requirements throughout the product lifecycle.

• Experience working cross-functionally with Clinical, Quality and Product Development teams.

• Understanding of clinical development programs supporting regulatory submissions and marketing authorizations.

• Experience with international regulatory submissions beyond Europe and the US is a plus.

• Previous experience as Deputy PRRC is considered an asset.

Technical knowledge

• Knowledge of medical imaging, oncology, pulmonology and/or radiology is highly desirable.

• Good understanding of MDR, post-market surveillance and vigilance requirements.

• Familiarity with global regulatory databases and registration processes.

Soft skills

• Strong project and priority management skills.

• Ability to manage multiple projects simultaneously and meet deadlines.

• Excellent communication and presentation skills.

• Collaborative mindset and ability to work effectively in multidisciplinary teams.

• Proactive, autonomous and solution-oriented.

• Ability to provide clear, transparent and structured reporting.

• Fluent English, both written and spoken.