Regulatory Affairs Manager H/F

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

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

Your main responsibilities

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

• Define and maintain the intended use of the product, indications for use, labeling, and associated documentation.

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

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

• Keep abreast of regulatory policies and regulatory requirements.

• Manage and maintain data in regulatory databases such as the FDA Device List, EUDAMED, and ClinicalTrials.gov.

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

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

• Act as Vigilance Delegate.

Why join us?

• Contribute to innovative medical technologies powered by AI.

• Work on products that have a 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 or PhD in Biological Sciences, Medical Sciences, or a related field.

Experience

• 3 to 5 years of experience in Regulatory Affairs in Medical Devices, In Vitro Diagnostic Medical Devices (IVDs), and/or Software as a Medical Device (SaMD).

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

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

  • US FDA submissions

  • CE marking according to EU regulations

• Solid understanding of regulatory requirements throughout the product lifecycle.

• Experience working collaboratively with Clinical, Quality, and Product Development teams.

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

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

• Previous experience as a PRRC Delegate 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.

Interpersonal Skills

• Strong project management and prioritization skills.

• Ability to manage multiple projects simultaneously and meet deadlines.

• Excellent communication and presentation skills.

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

• Proactive, self-directed, and solution-oriented.

• Ability to provide clear, transparent, and structured reports.

• Fluent English, both written and spoken.