Regulatory Affairs Specialist

Hermes Medical Solutions Ltd; Stockholms kommun; Hybrid; SEK 45,000 - 70,000; Full time

Job summary

Hermes Medical Solutions Ltd is seeking a Regulatory Affairs Specialist to join their team in Stockholm. This role combines strategic and operational regulatory work within a global MedTech environment, ensuring compliance with medical device regulations across various international markets.

In this position, you will collaborate with internal stakeholders and external partners to drive regulatory activities throughout the product lifecycle. The ideal candidate holds a relevant Master’s or Bachelor’s degree and has 2-5 years of experience in Regulatory Affairs.

The position offers a hybrid working model and emphasizes quality-focused, structured, detail-oriented candidates.

Qualifications

• 2-5 years of experience in Regulatory Affairs/Quality in a regulated industry.
• Solid understanding of medical device regulations and requirements.
• Experience collaborating with international distributors.

Responsibilities

• Drive and coordinate global regulatory registrations and maintenance.
• Prepare and submit regulatory dossiers for compliance.
• Act as the main contact for authorities and partners.

Skills

Regulatory compliance

English (fluent)

Strategic thinking

Detail-oriented

Education

Master’s or Bachelor’s degree in Engineering, Life Sciences, Medical Technology

Job description

Regulatory Affairs Specialist – Stockholm/Remote

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.

Examples 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

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 summer, according to agreement

Selection and interviews will be conducted on an ongoing basis.