Regulatory Affairs Specialist

Regulatory Affairs Specialist to Hermes Medical

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 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.

About Hermes Medical

Hermes Medical is a Swedish medical technology company with 50 years of experience developing innovative software solutions within nuclear medicine and molecular imaging.
 

As an independent software provider, Hermes Medical holds a unique position in the market and collaborates with customers and distributors worldwide.
 

Headquartered in Stockholm with approximately 70 employees globally, the company offers an international and entrepreneurial environment where innovation, quality, and collaboration are at the core of the business.
 

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 

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.
 

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 the summer, start date according to agreement 

Selection and interviews will be conducted on an ongoing basis.
 

In this recruitment, Hermes Medical collaborates with Dedicare Life Science. 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!