Interim Director Regulatory Affairs & Quality

For the role of interim Director Regulatory Affairs and Quality, we are looking for a resource who has experience from Life Science companies in strong development and who has good insight into what is required to comply with current regulations and standards.

Main duties:

• Can contribute and support various development projects focusing on Regulatory Affairs and Compliance throughout the product life cycle.
• Monitor new regulatory rules as well as changes to existing rules to ensure compliance with medical device regulations internationally.
• Ensure synergies and optimal use of resources to support the global corporate strategy.
• Ensure regulatory requirements and documentation around development, registration, labeling, sales, import and distribution.
• Liaise with authorities both nationally and globally and write, compile and update registration documentation.
• Experience in registering medical devices or medicinal products in the US and Europe and Japan. Risk analysis (ISO14971)
• Implementing and planning projects, organizing project teams, communicating with internal and external contacts.
• Authority to decide on recalls, deviations, and approve or reject contract manufacturers and suppliers on regulatory issues in projects developing new products, line extensions and upgrades according to launch plans.
• Plan and update submissions and regulatory updates worldwide to achieve market access (e.g. CE marking, PMA, 510k, HDE, IDE)

Who we are looking for:

• Solid experience in Regulatory Affairs and having worked in an environment with regulatory requirements according to regulations & standards.
• Responsible for coordinating responses to regulatory queries and for submitting and approving regulatory documents.
• Has been involved in the development of strategies and evaluation/compilation of the documentation needed for the approval of new products, renewals and change requests.
• Responsible and solution-oriented with good oral and written communication skills.
• You can argue your case while being open and humble - with a high level of integrity and the ability to look at the bigger picture.
• Able to absorb the content of standards, regulations and translate to the needs and realities of the business, and able to lead others when needed and independently drive activities.
• The assignment may lead to a permanent position if both parties find it desirable after the end of the interim assignment.

About the process:

The assignment is expected to last 10 months starting July 1st. We interview and present candidates on an ongoing basis to the client company and the latest application date is July 12.

Are you available and have the right background? Apply today!

The responsible recruitment consultant is Michael Schilling who collaborates with researchers Ida Eriksson.