Regulatory Affairs Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

We are looking for a Regulatory Affairs Specialist for Czech and the region.

This role is limited time - 1 year. We offer fully remote or hybrid workplace set up.

It is a great opportunity to join the RA area for those that are interested to grow in this area.

The main duties are listed below:

• Implement medical device registration/re-registration activities in the hub, manage the registration activities in distributor markets in close collaboration with our distributors and manufacturing sites,
• Ensure timely market access,
• Attend business opportunity meetings and prepare necessary documents to allow product registration, align with stakeholders on the registration priorities,
• Review the technical documents provided by manufacturers as per registration requirements,
• Report to Regional QRC the status of product registration of the countries under the responsibility of the role,
• Coordinate translation activities performed by suppliers,
• Act as Regulatory and Product Registration SME (Subject Matter Expert),
• Execute checks as per EU MDR article 14,
• Archive product registration certificates,
• Follow up regulation and standard changes for the responsible markets, inform related and key people in the company, ensure proactive actions are taken when needed to ensure timely compliance,
• Regulatory impact assessment for product changes,
• Keep the regulatory intelligence database updated following market requirements,
• Support for other QRC processes like field safety corrective actions.

Minimum requirements

• Two years of experience in regulatory operations in Medical Device or Pharma industry.
• University Degree, preferably from Scientific discipline.
• Experience in market access and registration across EU and non-EU countries; knowledge of countries like Serbia, Bosnia and Herzegovina, and Moldova is an advantage. 

Required Knowledge, Skills, and Abilities

• Working knowledge of medical device regulations (EU MDR, MDD, GDP) with a willingness to expand expertise.
• Sound knowledgee of Quality Standards including ISO 13485 Quality Management Systems.
• Proficiency in MS Office (Excel)
• Good level of English spoken and written, preferably Czech language as well.
• Team-oriented mindset and willingness to collaborate.
• Detail-oriented, diligent and responsible.
• Ability to manage multiple tasks and prioritize work effectively
• Strong communication and presentation skills
• Well-organized with a quality-focused approach.

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. 

If you have any questions, feel free to contact Natalia Bodirogic (natalia.bodirogic@getinge.com).