Senior Regulatory Affairs Manager - Denmark - MedTech

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.

Job Description:

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.

Key Responsibilities:

• 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.

Qualifications:

• 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