Regulatory Affairs Professional

Join a growing company with a strong purpose
Do you want to make a difference for people breathing, speaking, and living with a neck stoma?
And do you have a keen interest in the regulatory field of medical devices? Do you see structure and logic where others see chaos and bureaucracy?
When you join us, you will be making a difference every single day!
 

About the roles

Atos is on a steep growth curve where RA (Regulatory Affairs) plays a significant role in registering products in new markets as well as maintaining current registration in the 60+ countries where we are currently present. An important part of our registration maintenance is to remain compliant with current legislation in our active regions. One of those regions is the European Union, where a new regulation is being enforced, namely the MDR (Medical Device Regulation). Due to the increased regulatory requirements imposed on the Medtech industry, we are now expanding our RA department.

 

We are looking for two to three (2-3) Regulatory Affairs professionals in different seniority who can play a vital part in our Regulatory Affairs team in Sweden and assist in our transition from MDD (Medical Device Directive) to MDR. As a newly hired Regulatory Affairs professional your primary focus will be updating and reviewing our technical files prior to submitting to our Notified Body, and later correcting and responding to our Notified Body in a timely manner. In the longer term, once we are over the initial hurdle the tasks will to more traditional regulatory affairs activities, such as product registrations, document review, guidance on quality-related issues, QMS (Quality Management Systems) development and audit management. Regardless of what you do though, you will make a difference in people’s lives, every single day.

 

The Atos Medical Regulatory Affairs team is based out of Hörby in Sweden, so if you live and work in the area, that is of course a plus, but we do apply a hybrid model of working where multiple sites may be used. Hörby and Hyllie in Malmö are two, and Humlebæk, north of Copenhagen in Denmark and your private home are others that may be used.

Our RA-team in Hörby is primarily focusing on the laryngectomy range of devices. Our other RA-team in TRACOE medical located in Nieder-Olm outside of Frankfurt in the southwest of Germany, focuses on the tracheostomy range of devices. Both departments are part of a global function within Quality Assurance and Regulatory Affairs.

 

Your responsibilities


• Transition of higher-class product files from MDD to MDR.
• Product registrations in existing and new markets.
• Interpretation and application of regulations to provide local and global guidance.
• Document review and guidance on quality-related issues.
• QMS development and audit management.
• Quality related projects and networks.

 

About you

To be successful in these roles you need to have a keen interest in Regulatory Affairs, and you need to be detail oriented and thorough. You have good documentation skills and you like working in a structured and organized manner. You must enjoy working independently with many tasks in parallel and have the ability to prioritize, implement and complete tasks. You can turn complicated regulatory requirements into more easy-to-read operating procedures.

To fit in our culture, you are a true team player that loves to develop both yourself and others. You love to share your knowledge, and to make sure everyone keeps moving forward to reach common goals. You are unpretentious and driven by developing as a group and to reach collective goals together. To find new ways and approaches comes naturally for you.


For a more junior role we want you to have:


• A university degree within chemistry, biotech, engineering, biology or similar.
• Ability to interpret and understand regulations and standards.
• Knowledge of ISO13485, MDSAP, MDD or MDR and QSR - 21 CFR 820.
• Good grammatical skills in English and Scandinavian, spoken as well as written.


To be considered for a more senior role we want you to have:


• A university degree within chemistry, biotech, engineering, biology or similar.
• Minimum 3 years of experience from QARA within Medtech or Pharma.
• Experience of interpreting and understanding regulations and standards.
• Knowledge and experience in working under ISO13485, MDSAP (Medical Device Single Audit Program), MDD or MDR and QSR - 21 CFR 820.
• Good grammatical skills in English and Scandinavian, spoken as well as written.


If you also have the following characteristics or experiences, we will like you even more:


• Experience in compiling advanced product registrations g., 510(k), product dossiers and technical files for Notified Body reviews.
• Experience in product registrations and UDI (Unique Device Identification).
• Knowledge within chemical and biological evaluation and sterilization processes.
• German, Arabic, Mandarin, or additional language skills.

 

Does this sound like the perfect challenge for you? Please send your application today, the last day for applying is April 25th, but applications will be reviewed on an ongoing basis, and we are hiring right now so do not wait, apply now!

 

If you have any questions, or just want more information of the positions, feel free to reach out to Head of RA, Karolina Nilsson, via email: karolina.nilsson@atosmedical.com or VP of QA/RA, John Wennborg via email john.wennborg@atosmedical.com

 

About Us

Atos Medical develops and sells medical devices, driven by the desire to make life easier for people living with a neck stoma in over 90 countries.

 

Since our foundation in 1986, we have cemented ourselves as the leaders in neck stoma care, and today our business includes innovative products in laryngectomy and tracheostomy care to help people breathe, speak, and live well.

 

We are a truly global organization with Swedish roots made up of about 1200 employees and 25 subsidiaries worldwide. Atos Medical is a part of Coloplast A/S.

 

For more information, please visit our career page www.atosmedical.com/about/life-at-atos-medical/