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.

Newly Created Role - Excellent opportunity for a Regulatory specialist to join a dynamic and growing team for a market lading organisation.