Senior Regulatory Affairs Officer for medical device development
Phillips-Medisize is looking for a Senior Regulatory Affairs (RA) Officer for Global Innovation Development EU in Copenhagen, Denmark. If you have a passionate interest in creating unique products for people who need medical treatment and want to be part of a rapidly expanding project organization, you might be the one we are looking for.
About the position:
To support our strategy and growth we need to expand our capabilities and systems to comprise sterile and implantable class III medical devices. Likewise we have an ambition to build global regulatory capabilities. As Senior RA Officer you will lead this development work together with the rest of the current RA team based in Struer, Denmark. The team is responsible for the regulatory approvals in different countries executed either by ourselves or in close cooperation with customers. Your main responsibilities will be:
- plan and drive development of our regulatory set up and systems to support class III sterile/implantable medical devices
- plan and drive development of our regulatory set up to support global product approval set up
- actively support development of global RA function across Phillips-Medisize
- to participate in medical device development projects to lay out the regulatory strategy
- to execute the agreed regulatory strategies and coordinate regulatory work with customers and authorities.
The position requires both internal and external cross functional cooperation and communication.
What we are looking for in you:
Master or Bachelor degree in Natural Science or similar qualifications. More than 10 years proven experience as a RA professional in the medical device industry.
You also have proven experience with:
- Class III medical devices (sterile/implants)
- Medical device quality management systems and standards (eg. ISO 13485:2016, MDD and MDR)
- Preparing Design Dossier/Technical File for CE marking, preparing 510(k) package to FDA, preparing Device master File (MAF) to FDA and Premarket Approval (PMA)
- Obtaining and maintaining regulatory approvals
- Keeping overview of regulatory commitments and driving necessary actions to maintain approvals for systems and products
- Authority inspections/audits
You are self driven and have project manager skills. You create the right solutions that are supported across the organisation. You have a systematic approach to your work and you deliver well-structured results. You have a holistic can-do attitude, a pro-active approach and deliver on time. You thrive in a changing environment and by working across many disciplines – some of these are probably new to you. You have excellent written and verbal communication skills in English
We offer you
- A challenging position in an international innovative and successful company in growth
- An opportunity to become part of a team of dedicated and highly qualified RA colleagues based in Struer, Denmark
- Cooperation in cross-functional project teams with great opportunities to influence the daily work
- Participation in developing the RA area to support a more global set up and more complex products
- Well-structured training and continuous development of your competencies.
- Flexible working hours
- Salary on a competitive level
Are you curious to get more information?
For more information and details on the position please contact Director, Quality and Regulatory Jess Pihl on phone +45 26 75 32 00.
We look forward to hearing from you.
We processes applications continuously. Please submit your application and CV soonest possible to by pressing the “apply” button.
The Company – in short
Phillips-Medisize A/S is an excellent expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide.
Phillips-Medisize A/S is a part of Molex. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch.
Read more about Phillips-Medisize A/S at www.phillipsmedisize.com or follow us at LinkedIn.