Regulatory Affairs Specialist

We are looking for an ambitious and detail-oriented individual to join our regulatory team, which is responsible for the company’s compliance with applicable laws and regulations relating to medical device manufacturers. The Regulatory Affairs Specialist will participate in cross-functional projects relating to the design and development of medical devices, market registrations, and implementation/improvement projects to ensure regulatory compliance of the manufacturer and the medical device throughout its life cycle.

Function & Responsibilities

• Prepare regulatory documents for medical device submissions.

• Compiling technical documentation data packets for distributors to support international product registration.

• Participates in creating and maintaining technical documentation (TD) to comply with EU MDR and other country/market-specific requirements for TD

• Participates in developing, implementing and maintaining the necessary internal procedures to ensure the company’s ongoing compliance with national and international regulations/requirements

• Participates in improvement projects related to the Quality Management System

• Research applicable national and international standards and guidance to provide input to the company’s ongoing compliance and medical device state-of-the-art status

• Participates in design reviews and conducts regulatory assessment/gap analysis

• Participates in market surveillance of medical devices

• Provide support during audits conducted by Notified Body (NB)/Conformity Assessment Bodies (CAB) and Regulatory Authorities (RA) and formulate the appropriate response and corrective actions

Education and Qualification requirements

• B.Sc degree in Biomedicine, Engineering, or other relevant education or equivalent experience required in regulatory affairs within the medical devices or pharmaceutical industry or equivalent

• Good planning/organizational and problem-solving skills and techniques

• Exercise judgment within defined procedures and practices to determine appropriate action

• Technological skills with the capability to understand the product technology/design as well as tests, standards, guidance, and other methodologies needed to demonstrate and maintain compliance with applicable regulations

• Experience with medical device regulatory affairs, submissions, compliance programs, and quality systems is preferred

• Excellent English skills, both verbal and written

The right person for the position

• You have an analytical ability as you will be performing assessments and evaluations

• You have strong communication skills working within a collaborative environment

• You need to have strong attention to detail as you will be assisting with ensuring and maintaining compliance of the medical devices throughout their lifetime

• You need to be organized and comfortable managing multiple work tasks

The Job application, CV, and cover letter may be submitted in English or Icelandic.

We are always interested in talented individuals who share our passion for improving people’s lives. Nox Medical embraces diversity. As an equal opportunities employer, we believe the foundation of our dynamic and pioneering spirit starts with a fair and inclusive culture. Our company culture focuses on bringing unique ideas and people together to spark innovation and teamwork.