Are you interested in becoming part of an international and market leading medical technology company whose products make a huge difference for patients, healthcare professionals and societies all around the world? Apply to be a member of the Strategic Regulatory Affairs team at Getinge (Maquet Critical Care). As one of the first companies in Sweden to achieve a MDR certificate for our Class IIb products, we strive to be at the front of regulatory compliance and quality process development.

The Position
This position offers you a great opportunity to work cross-functional, locally, and globally, with a wide variety of stakeholders inside the organization. It is an excellent chance to take part in improving world class med-tech products in a challenging regulatory environment within a global and fast-paced manufacturing organization. As a Regulatory Affairs Manager within the strategic part of the Regulatory Affairs team, you will take ownership for the country registrations for the product area of Anesthesia, Ventilation and Perfusion. The main focus for this team is in-time licence renewal and new product registrations for all countries after CE marking and control regulatory product approval for shipments. The regulatory team strive for excellence in the regulatory process by taking a leading role in international standardization and development of Getinge global processes. You will have the opportunity to collaborate in an open climate, with a diversified team through the whole product life cycle, from idea to release the product to market and through post market surveillance. This role leading cooperation between different sites within Getinge on a global level.

The main responsibilities and tasks for a Regulatory Affairs Manager at Getinge are:

• Strategic regulatory planning, coordination and implementation of registrations for EMEA/APAC/LATAM region
• Support Product Registration Governance forum (”Prioritization Process”) for Solna and Feldkirchen
• Oversee/coordinate and maintain all (re-)registration activities & follow ups for Solna and Feldkirchen (ACT) until approval / completion in alignment with ComOps/ Product Management & Regional QRC (SSU RA)
• Analyze / secure regulatory & compliance information available from any source in alignment with Operational RA
• Compile / review additional country specific Registration Documentation (with support of Operational RA if needed)
• Obtaining government documents, certifications, Free Sales Certificates, apostilles, etc.
• Control regulatory product approval for shipments (e.g. Global Trade System or similar; with strong support of Operational RA)
• Maintenance of data/document storage systems
• Ensuring the receipt and maintenance of international approvals
• Completion of annual establishment registration / license renewal / device listing
• Monitoring of Regulations / Ordinances / National Standards / Guidance Documents (with strong support of Regulatory Intelligence)
• Support implementation of Regulations / Guidance Documents
• Participate in the standards & regulations assessment process by supporting gap analysis

We strive for all our employees to be able to achieve a good work-life harmony. We have introduced a flexible approach to our workplaces, and therefore you will have the opportunity to work remotely in this position a certain part of the week.
The position is located at our site in Solna but will require daily communication with stakeholders world-wide.

Is this you?
For this position, we want you to have the following background:

• Experience within QA/RA and/or R&D, preferably from the medical device industry