RA Specialist

Regulatory Affairs - Immunology - Medical Devices

With reference to the Regulatory Affairs Manager, you will be a part of the RA function - a team of highly skilled and specialized colleagues. We are responsible for planning and executing the regulatory tasks required in connection with new projects and products on the market. Your overall responsibility is being RA specialist for AQT - this requires special knowledge within immunology and software. Top focus will be AQT clearance for assays as well as continue the regulatory processes as requested from Marketing. Due to our development strategy and more focus on the regulatory clearances we are now looking for two new colleagues within Regulatory Affairs.

Successful execution of these tasks depends on cross-functional cooperation with QA, R&D, Production, Sales and Marketing and other departments. Together with our local sales companies and Danaher's QA/RA organization, we are responsible for preparing and compiling regulatory dossiers to ensure that their content is in accordance with internal and external guidelines

Challenges
Your responsibilities and tasks will among others include:

• Project participation: Secure that the regulatory requirements are implemented and shared in the project group, levelling the work ultimately needed to secure that files are approved and meeting the requirements set forth by Danaher and multiple bodies of legislation.
• Product lifecycle management: Supporting Product Managers ensuring compliance throughout the entire product lifecycle (e.g. changes in products or changes in legislation).
• Procedures: Implementation of new procedures, including the writing and editing of SOPs.
• MDR/Vigilance: Ensuring that MDR/Vigilance are handled in accordance to procedures and internal/external standards.

Qualifications
"Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success:

• A relevant scientific degree (preferably Master Degree in Pharmacy, Biology and/or Engineering)
• Strong experience from within Regulatory Affairs, preferably medical device legislation (IVD, MDD)
• Experience in from the business environment of medical devices is preferred however and alternative path could also be pharmaceuticals, food industry or the legislative side.
• Knowledge of the current ligislation on software (i.e. GAMP guidelines)

As a person you

• Are positive and open-minded adding energy to our team by taking responsibility and are engaged and committed about what you do.
• Communicate effectively and act proactively
• Focus on targets and results and work well independently as well as in teams
• Embrace changing priorities and focus areas
• Speak and write English at a professional level

We offer you
A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for further education and training, flexible hours and a range of other staff benefits.

For further information, please contact RA Manager Lone Rønnemoes Pedersen at +45 3827 3335 or VP RA/QA Jana S. Hellmann at +45 3827 3389.

Interviews will be held as soon as relevant candidates have been identified
...so please do not hesitate to apply. Start the application process by visiting our Career Site at www.radiometer.com/jobs and follow the guidelines. Please upload relevant documents and fill out as many fields as possible in the process. This will increase the chances of a right match and also put you in a better position if a similar job matching your requirements and skills should become vacant.

Make an impact on life
The difference between life and death can be just a few minutes. Radiometer's diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2100 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer's leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of DKK 2.5 billion and is owned by US-based Danaher Corporation.

Skriv venligst i din ansøgning, at du så annoncen hos medrek.co.uk