We are now looking for an engaged and experienced Regional Regulatory Affairs specialist to join the Linde Gas AB team within the region REN.
Linde Gas AB is a leading industrial gases and engineering company that serves customers in various industries, including healthcare. We live our mission of making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful and helping to sustain, decarbonize and protect our planet.
About the position
As Regional Regulatory Affairs specialist, you will define the regulatory strategy for the medical gas products and ensure that it is executed according to plan enabling business unit strategy in compliance with regional regulations. You will act as project manager for the Regulatory Competency Center (RCC) for the region REN, a role where you will collaborate closely with other departments and communicate with regulatory agencies and authorities. This responsibility will include confirmation of the regulatory strategy, authoring of documents, coordination with required contributors, compiling, publishing, and submitting registration dossiers. You will lead and execute required post-licensing activities for exampel renewals, variations, line extensions, supplements for approved medicinal gases products.
In this role, your responsibilities will also include:
- Keeping up to date with laws and regulations relevant to product portfolio
- Regulatory impact assessment of changes, manage projects and provide regulatory input where needed
- Write and update regulatory procedures within the Linde Quality Management System
- Act as a backup of MD regulatory colleague, support on Medical Device activities
- Submissions of files, variations to authorities etc.
- Maintaining data in our regulatory tracking system
- University degree in medical life science such as pharmacy, biology, (bio)chemistry or equivalent
- Several years of Regulatory Affairs experience within pharma, preferably within an international company
- Solid European pharma regulatory knowledge
- Medical device regulatory knowledge and/or experience is a plus
To succeed in this role, you are
- A team player with excellent communication and negotiating skills
- Well-organised and resilient
- Open minded and able to think outside of the box
- Result driven and committed to reach deadlines, with a mindset for process improvement
This is a full-time position with desired start date as soon as possible. For this role, we are primarily looking for a person in Stockholm, as the main office is located in Solna. As this position can be remote it also works if you live elsewhere in Sweden.
Any questions about the position? Contact us!
Ellinor, tel: 076 511 54 06, mail: [email protected]
Anna-Maria, tel: 070 589 23 19, mail: [email protected]
Welcome with your application as soon as possible. We process applications and conduct interview continuously during the application period!