Description

Phillips-Medisize, a Koch Company, is building solutions in partnerships with global biopharmaceutical companies to service the expanding need for self-administrated drug delivery devices suitable for especially liquid injectable drugs. To support this growing market with faster timelines to market combined with reduced development risks, several different medical device product platforms are currently in development to provide customers with a head start for launching new drugs.

Do you want to design safe and reliable medical devices, bringing our clients' life-changing solutions into the hands of patients and helping patients to get better treatment?

Then join us and work together with your highly skilled colleagues to bring new products to market in a fast-growing and successful global company!

We are currently hiring a
Registration Specialist (m/f/d)/ Regulatory Affairs Medical Devices

fulltime in Virum or Struer, DK in a hybrid working model.
What You Will Do In... Your Role
• Execute regulatory strategy by generating country-specific regulatory documentation.
• Assemble regulatory submission package for a selection of countries worldwide.
• Submit required documentation to gain market clearance.
• Interact with customers and regulatory authorities to ensure regulatory clearance.
• Identify and interface with local representatives worldwide.
• Review and ensure compliance of the technical documentation.
• Maintain market clearance and assess change impact on approval status.
• Support development and improvement of the regulatory affairs & submission process.
• Maintain a deep understanding of country-specific regulatory requirements.
• Work in close cooperation with the project manager and the regulatory team.
The Experience You Will Bring
• Bachelor’s degree in life science, engineering or equivalent.
• First proven experience, min. of 2 yrs. in regulatory affairs within the medical device / pharmaceutical industry.
• First experience in preparing technical documentation intended to be use for a submission.
• Strong organizational skills, quick learner, and the ability for multi-tasking.
• Ability to work in an evolving, challenging, and multi-disciplinary environment
• Proficiency with MS Office.
• Excellent written and verbal communication skills in English
What Will Put You Ahead
• Experience with combination devices (class IIb)
• Experience in medical device approval in one or more of the following Japan, India, China, Eurasian Union, Australia & Gulf Countries and/or Brazil.

What We Offer
• Opportunity to join a growing team working in a fast pace and multidisciplinary environment.
• Collaborate with the regulatory department of leading pharmaceutical companies around the world.
• Mobile Phone Broadband connection at home
• Private health insurance Competitive pension scheme

If you are interested in this role or know someone who would be a good fit, please apply directly through the link or forward this role. We are looking forward to your application!

#LI-SR7
Virum Denmark

Salary Criteria