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.
- 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.