Medical Writer

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?

Are you passionate about clinical evidence and have a keen interest in working according to the Medical Device Regulations? If so, then we might just have the opportunity for you.

 

About the role

We are currently expanding our Medical and Scientific Affairs team with a Medical Writer, based in our Head Office in Malmö, Sweden. 

This is a full-time role reporting directly to the Vice President of Medical and Scientific Affairs. 

We are looking for a highly motivated candidate to join our team. As a Medical Writer you will write clinical evaluation and post-market clinical follow up plans and reports in compliance to applicable regulations, standards, and guidance documents, such as MDR, MEDDEV 2.7.1, and MDCG, within the clinical field of laryngectomy and tracheostomy. The role requires excellent medical writing and documentation skills with attention to detail, consistency, and integrity of data. Since you will collaborate with other teams such as Regulatory Affairs, Marketing and R&D, we see that you enjoy working in a cross-functional environment.

Ideally, you have 1-3 years of previous related work experience in the medical device industry. Here you will contribute with your enthusiasm and skills. In return, we can offer you an exciting opportunity with a challenging job and great opportunities for further professional and personal development. Does this sound interesting? If so, we will be happy to hear from you!

 

Your responsibilities


• Identify, evaluate, and summarize clinical evidence including data from sources such as clinical investigations, literature, databases, and post-market clinical follow up studies and activities.
• Regulatory medical writing of clinical evaluation plans (including clinical development plans) and reports, PMCF plans and reports, as well as SSCPs.
• Provide input to new medical device development and product claims.
• Contribute to regulatory submissions and audits of related documentation.

 

Qualifications


• MSc within (bio)medical sciences (or equivalent)
• 1-3 years of related work experience in medical device industry
• Understanding of EU regulatory requirements (MDD, MDR, MEDDEV, MDCG)
• Ability to review and summarize scientific publications and product documentation, medical writing

 

Your skills and competences


• Excellent verbal and writing skills in English
• Strong medical writing and scientific reference software skills (such as EndNote)
• High working capacity and delivery according to plans and timelines

 

About you

To succeed in this role, we believe that you have strong documentation skills and a keen interest in working according to applicable regulations, standards, and guidance documents. You have previous related work experience in the medical device industry and a proven track record of delivering clinical evaluation and/or post-market clinical follow up plans and reports. You are also naturally proactive and able to use your experience to improve our processes for clinical evaluations and PMCF.

 

Location:

This role is based in our Head Office in Hyllie, Malmö, Sweden.

 

How to apply:

Does this sound like the perfect challenge for you? Please send your application in English today. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found. Preliminarily, interviews will start in August.

If any questions, feel free to reach out to Allana Kelley, VP Medical and Scientific Affairs at Atos Medical, via Allana.kelley@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/