Regulatory Affairs Specialist - Nordics

Job Description

Regulatory Affairs Specialist - Nordics

 

Our client is a global healthcare leader who helps people live more fully at all stages of life. They have a portfolio of life-changing technologies spanning the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.  They are currently looking for a Regulatory Affairs Specialist for the Nordic region. 

 

Primary Job Function

 

  • Comply with legislative and regulatory acts, and processes relating to the placing of medical devices on the Nordic Market.
  • Support the Commercial organization with requests for information to support product tenders and launches in the region.
  • Maintain excellent relationships with the National Competent Authorities.

 

Core Job Responsibilities

  • Participates in the development of a regulatory strategy for new and existing devices together with regulatory affairs management.
  • Support new product introductions, tender and reimbursement activities
  • Monitors new regulatory requirements related to the medical devices in the Nordics
  • Improves professional knowledge and skills.
  • Liaise International Units as required to answer regulatory queries and ensure that local processes meet regulatory requirements.
  • Implement databases and tracking tools to ensure projects and commitments are adhered to.
  • Provide metrics, reports and feedback to management - tracking of regulatory activities.
  • Support Senior Management and leaders as required
  • Review and approve locally generated advertising and promotional (A&P) materials
  • Ensure adherence to company policies and procedures.
  • Keep up to date with and communicate on requirements of the local legislation and guidance in the Nordics relating to medical devices and ensuring their safety.
  • Ensure compliance with training requirements, ethical code of business conduct, and company internal requirements.

 

Requirements

 

  • Educated to degree level, preferably within a scientific area (medical, pharmaceutical, biomedical engineering) or equivalent
  • Knowledge of Nordic regulatory requirements for medical devices is required.
  • Minimum 2 years’ experience in a similar role in regulatory affairs or clinical covering the Nordic Region in a regulated environment is required, and preferably in the medical devices/healthcare sector.
  • Experience of working within the context of a certified Quality System and regulated environment is desirable.
  • Fluent in Scandinavian languages and English.
  • The ability to act with honesty and integrity always.
  • The ability to show initiative and interact effectively with colleagues.
  • Excellent teamwork and focus on achieving business goals.
  • Excellent communication and negotiation abilities.
  • Good attention to detail and strong analytical skills are needed to perform this role effectively.
  • Ability to develop some technical understanding of medical devices.
  • Task oriented and a completer / finisher.