Hermes Medical Solutions
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Are you looking for an international Regulatory Affairs role where you can combine strategic thinking with hands-on regulatory work in a global MedTech environment?
Hermes Medical Solutions is now looking for a Regulatory Affairs Specialist to join a growing organization, where you will play a key role in ensuring global regulatory compliance and enabling continued international expansion.
This is an opportunity to work closely with internal stakeholders, authorities, distributors, and external partners worldwide in a role with significant responsibility and broad exposure.
About The Role
This is a specialist role within Regulatory Affairs, focused on ensuring continuous compliance with applicable medical device regulations across global markets while supporting business growth through successful product registrations in new and existing countries.
The role combines operational and strategic regulatory work and involves close collaboration with internal functions as well as international partners and authorities globally.
You will primarily work with registration outside Europe and North America, with a strong focus on markets in South America, Asia, and Australia.
Working closely with the RA Manager and Chief Quality & Regulatory Officer, you will play an important role in driving regulatory activities throughout the product lifecycle.
Exemples Of Responsibilities
- Drive and coordinate global regulatory registrations, renewals, updates, and lifecycle maintenance activities across international markets
- Develop and support regulatory strategies for new and existing markets in collaboration with the RA Manager and Chief Quality & Regulatory Officer
- Prepare, compile, review, and submit regulatory dossiers and ensure compliance with country-specific regulatory requirements
- Act as the main contact towards competent authorities, distributors, and external regulatory partners globally
- Assess product classifications and evaluate regulatory requirements for expansion into new international markets
- Maintain and review regulatory documentation while ensuring high quality and regulatory compliance standards
- Support internal compliance activities, inspections, SOP reviews, and supplier evaluations of external partners and service providers
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We Are Looking For Someone Who
- Holds a Master’s or Bachelor’s degree in Engineering, Life Sciences, Medical Technology, or another relevant field
- Has 2-5 years of experience within Regulatory Affairs/Quality in a regulated industry
- Has a solid understanding of medical device regulations and regulatory compliance requirements
- Has experience interpreting and applying regulatory requirements in international markets
- Is comfortable working independently and driving regulatory activities forward
- Has experience collaborating with international distributors, authorities, or external partners
- Communicates fluently in English, both written and spoken
It Is Considered a Strong Advantage If You Also Have
- Experience working with medical device software or Software as a Medical Device (SaMD)
- Experience with global product registrations
- Experience working with international distributor markets
- Swedish language skills
Personal Qualities
We place great emphasis on personal suitability and believe that you are structured, detail-oriented, and quality-focused, with the ability to prioritize effectively in a dynamic environment.
You are solution-oriented and confident in making regulatory assessments while balancing quality and efficiency in your work. You are also communicative, proactive, and comfortable working in an international environment with many stakeholders and interfaces.
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Practical Information
- Employment type: Full-time
- Working model: Hybrid, with at least 50% office presence for Stockholm-based employees
- Reporting to: Chief Quality & Regulatory Officer
- Preferred start date: After summer, according to agreement
Selection and interviews will be conducted on an ongoing basis.
In this recruitment, Hermes Medical Solutions collaborates with Dedicare Life Science. If you like to apply for this position Apply Here. If you have any questions, you are warmly welcome to contact the responsible recruitment consultant.
Lisa Meijer
Recruitment & Staffing Manager +46 76 215 19 83
lisa.meijer@dedicarelifescience.com
Jessica Törnquist
Recruitment & Staffing Manager +46 76 506 07 05
jessica.tornquist@dedicarelifescience.com
We kindly decline contact from other recruitment and staffing agencies regarding this process.
We look forward to receiving your application!
About Hermes Medical Solutions
Since its establishment in 1976 in Stockholm, Sweden, Hermes Medical Solutions continuously innovates to enable faster and more personalized diagnosis and therapies in molecular imaging. The company was first to develop SPECT reconstruction software and dual-head whole body scanning and first to introduce medical image fusion software for combined viewing of images from different scanners. With Hermia, we empower healthcare professionals with state of-the-art software for all clinical scenarios into one vendor-neutral software suite. Combining leadership in innovation for NM/MI software with customer-driven service is our mission and our success lies in our close and longstanding collaboration with our customers to meet their software, support and service needs. The result is improved quality in patient management and decision support for thousands of healthcare providers and their patients worldwide.
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