The company i am partenred with is a dynamic and innovative small medtech based in Denmark, specializing in the field of orthopedics. They are committed to revolutionizing the orthopedic industry by developing cutting-edge medical devices that improve the quality of life for patients. As they continue to grow, they are seeking a highly motivated and experienced Senior Regulatory Affairs Manager to lead their regulatory affairs team and ensure compliance with local and international regulations.
As a Senior Regulatory Affairs Manager, you will play a pivotal role in guiding their regulatory strategy and ensuring that their orthopedic devices meet the highest standards of quality and compliance. You will collaborate with cross-functional teams and regulatory authorities to secure approvals, maintain compliance, and drive our mission forward.
Develop and implement a comprehensive regulatory strategy for the successful market entry and ongoing compliance of our orthopedic devices in Denmark and international markets.
Prepare and submit regulatory applications and documents to health authorities, ensuring timely approvals for new products, modifications, and renewals.
Monitor and interpret changes in regulatory requirements, standards, and guidelines, and ensure the company's products and processes are compliant.
Identify potential regulatory risks and develop strategies to mitigate them, ensuring minimal impact on the business.
Collaborate with R&D, quality, clinical, and other departments to align regulatory objectives with product development and quality management processes.
Maintain accurate and up-to-date regulatory documentation, including technical files, design dossiers, and other relevant records.
Lead and assist in regulatory audits and inspections, including preparation and response to regulatory authorities.
Review and approve product labeling and promotional materials to ensure compliance with regulatory requirements.
Report and escalate regulatory issues to senior management and provide guidance on potential impacts.
- Bachelor's or advanced degree in a related field (e.g., regulatory affairs, life sciences, engineering).
- A minimum of 5 years of experience in regulatory affairs within the medical device industry, particularly in orthopedics.
- Strong knowledge of Danish and international medical device regulations, including ISO 13485 and MDR/IVDR.
- Proven track record in successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills, with the ability to work in a collaborative team environment.
- Project management and leadership skills.
- Attention to detail and analytical thinking.
- Fluent in English and Danish, both written and spoken