FIRST TIME RIGHT – The right tool, for the right patient at the right time.

Through empowering physicians with Standardized Molecular Imaging Software solutions, Hermes Medical Solutions delivers increased efficiency, accuracy for diagnosis and personalized treatment of patients. The result is improved quality and outcomes for healthcare providers who are pursuing refined clinical pathways in Precision Medicine.

Hermes Medical Solutions solves the global challenges in Molecular Imaging by addressing interrupted clinical workflows, lack of standardization and access to absolute quantification. Through our solutions, our customers address economic pressure in healthcare without sacrificing quality of care. For more than 40 years, we have been delivering the best in workflows, connectivity and clinical software solutions.

http://www.hermesmedical.com

 

Regulatory Affairs Manager

As part of QA/RA you will contribute to make quality medical device software available for patients


PeakSearch is recruiting a Regulatory Affairs Manager for the global highly innovative company Hermes Medical Solutions. Hermes Medical Solutions provides systems and software to visualize and analyze image data from various modalities in nuclear medicine.

The QA/RA team is central to the company’s business as it is responsible not only for product market clearances and manufacturer certificates, but also for the corporate Quality Management System and the quality assurance of products. As part of QA/RA you will contribute to make quality medical device software available for patients.

You will be the source of regulatory information within the company and responsible for looking up any relevant requirements in different contexts. You will also be the person performing the regulatory administration needed in all applicable markets world-wide (main markets are Europe, Canda and the US).

One of your first tasks will be to obtain market clearances for our new product versions and get an overview and create a structure for the company’s regulatory status (all products in all markets). Further tasks will be to ensure regulatory data quality and construct a good system for maintenance of this going forward.

Main tasks

- Manage/perform registrations and other regulatory administration
- Plan product submissions, file new submissions and obtain market clearances
- Identify market requirements and assist CQRO and our subsidiaries with regulatory questions
- Lead or contribute to regulatory projects and vigilance activities
- Contribute to regulatory data quality and other QA/RA tasks, as necessary

Important skills

- Ability to navigate, search and find information
- Experience from regulated area / understanding of working within a regulated area (Plus if Medical device, Double plus if Medical device software)
- Alternatively experience as a software developer / system developer / quality engineer/ product developer/ validation engineer/ product manager R&D in the medical device industry with interest in regulatory affairs
- Document handling, able to structure and reason
- It’s an advantage, but not required, to speak Swedish, have experience from software industry and knowledge of ISO 13485, MDD/ MDR and QSR

Competences / personal characteristics

- Pragmatic, Flexible
- Solution-oriented
- Structured, Meticulous
- Good communication (adapt to different settings / people)
- Open-minded and able to discuss different options to help to find solutions on how to implement requirements (able to interpret requirements in different ways)

Opportunities

- You will be part of the company's future venture, to provide systems and software to visualize and analyze image data from various modalities in nuclear medicine
- You will have a leading role in an important and exciting journey
- You will work in a global, highly innovative company with a flat organization with short decision-making paths
- You will work in a team of professional, dedicated and skilled colleagues from different parts of the world with great pride in their product. Ultimately, your purpose will be to save lives
- You get great responsibility and the opportunity to work in modern premises in central Stockholm in a non-prestige environment with a strong focus on development and progress

Contact, information and application:

For more information and application please contact Andrea Backlund or Magnus Klingberg Sr Recruitment Consultants at PeakSearch.

Andrea Backlund
Mob. +46-70 235 67 96
Email. andrea.backlund@peaksearch.se

Magnus Klingberg,
Mob. +46-70 678 09 92
Email. magnus.klingberg@peaksearch.se