QM/RA for Medical Device Company in Trondheim with possibility to work remote!

This position shall lead in the preparation and submission of medical device regulatory applications for the EU Market, in compliance with the MDR, and eventual international medical device regulatory submissions.

The Regulatory Affairs Specialist will act as main responsible for the Quality Management System (QMS) certified to ISO 13485:2016. A good quality for this position is to act independently to identify and resolve problems, provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

Job description

• Prepares robust regulatory applications supporting the EU Market to achieve departmental and organizational objectives. Supports EU MDD/MDR transition activities and maintains product technical files.
• Creates, reviews and approves engineering change order and prepare Regulatory assessments.
• May act or assist as a Person Responsible for Regulatory Compliance (PRRC) on core product development teams, communicates regulatory requirements and impact of regulations to the development team.
• May act or assist as liaison between the Company and the Notified Bodies and/or Competent Authorities.
• Maintains ongoing surveillance and analysis to ensure submission requirements are current, up-to-date and the submission is filed accurately with the appropriate authorities.
• Review device labeling and marketing materials for compliance with submissions and applicable regulations.
• Manage and maintain Company QMS, certified to ISO 13485:2016.
• Support all Company initiatives as identified by management and in support other regulatory requirements.
• Complies with Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related Regulatory Affairs duties and responsibilities, as assigned.

General Qualifications

• BS degree, MS preferred (degree in a technical discipline highly preferred).
• A minimum of 2 years’ experience in Quality Management or Regulatory Affairs within the medical device industry.
• Experience in product development and/or clinical trials
• Working knowledge of EU MDD/MDR.
• Experience with international submissions and notification processes, Asian regulations and/or US FDA.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications in English.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to identify and solve problems and work independently with little oversight.
• Company is located in Trondheim. Ideally this position would reside in Trondheim however if not then travel will be required.