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Job Title: Director, Global Regulatory
Location: Solna, Stockholm, Sweden (Hybrid possible)
Employment Type: Permanent (part-time) position

Immedica pharma has experienced remarkable growth in recent years, and we are now looking for a Director, Global Regulatory, to further strengthen our Global Regulatory Affairs department. 
In this position, you will play a key role in developing and executing the regulatory strategies for the Immedica portfolio, both pre- and post- marketing authorization, with a focus on clinical development. 
Primary tasks could be to prepare and compile global regulatory documents required for competent agency interactions, variations, renewals, responses to agency requests or other compliance updates.
You will be part of the regulatory department working closely with other functions of the company, such as Medical, Clinical Operations, QA, Manufacturing and Supply to secure the quality and supply of the products. 

Job description and responsibilities

• Regulatory strategic and operational responsibility for assigned products/projects to support new marketing authorizations and major variations
• Preparation of regulatory documents to support new registrations and updates to Immedica current portfolio in a global setting with a focus on clinical parts of regulatory dossier
• Lead competent agency interactions for assigned projects towards EMA, US FDA and national agencies throughout Immedica territory as applicable
• Participate in cross-functional internal projects as a regulatory expert for assigned products/projects 
• Train and support junior colleagues within the department as regulatory senior expert
• Participate in updates and implementations of relevant SOPs

Experience and competence

We are looking for someone with a university degree in pharmacy/ chemistry/ biotechnology or equivalent, preferably with +15 years of experience working in regulatory affairs in the pharmaceutical industry or Medicinal Products Agency with a focus on clinical development. 
Experience in medical writing, clinical operations, regulatory strategies in rare diseases is required. Experience in leading regulatory interactions with FDA, EMA, MHRA, PMDA and additional national agencies is a plus.
Excellent knowledge of English, both spoken and written, is essential, additional languages is a bonus.

Personal Qualities

As a person, you are independent, ambitious, clear and meticulous. You have good teamwork skills and like to tackle new things. The ability to structure, obtain information and investigate information that is new to you is valued. You like to share knowledge and information in internal and external settings.
We welcome applicants from all backgrounds, and we celebrate diversity, promote inclusivity, place great emphasis on personal qualities and alignment with the company’s core values.

How to apply

This is a part-time position. If you wish to apply, please send your resume and application to [email protected]. Applications are reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

About Immedica

Immedica is pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care within our focus areas: genetic & metabolic diseases, hematology & oncology and specialty care. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory and medical affairs as well as market access. Serving patients in more than 50 countries, Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need.
Immedica was founded in 2018 by investment company Impilo and buy-in management and employs today more than 150 people across Europe and the Middle East. Approximately 80 are based in the headquarters in Life City, Hagastaden, Stockholm. 
At Immedica, our core values are the foundation of our culture and the driving force behind how we operate, innovate, and collaborate. These values guide every decision we make, shaping our commitment to patients, partners, and colleagues. Open & Honest: We foster transparency, integrity, and trust through open communication. Effective: Focused on delivering excellence, we prioritize impact and quality to make a real difference in the rare disease landscape. Empowered: We encourage collaboration and ownership, creating a supportive workplace where all team member’s contributions drive innovation and growth. 

We look forward to welcoming you to the Immedica team!

Job Title: Senior QA/RA Manager 
Location: Stockholm, Sweden 
Employment Type: Full-time position 

Immedica Pharma has experienced remarkable growth in recent years, and we are now looking for a Senior QA/RA Manager for medical devices, to further strengthen our team. 

Although Immedica is mainly a pharmaceutical company, the company has recently incorporated a class A (IVDR) in-vitro diagnostic medical device (IVD) into our portfolio and a second IVD is in project phase. These devices are not just additions, they are critical enablers for the successful global launch of one of Immedica’s flagship products within Rare Metabolic, a treatment for an ultra-rare disease. 
Ensuring regulatory and quality compliance for these devices is essential to enabling patient access worldwide and achieving our ambitious expansion goals. 

In this role, you will play a key role in shaping and adapting operations to effectively incorporate and manage IVD products in line with applicable regulations globally. 

You will be part of the Global Quality department, working cross functionally within Immedica and in close collaboration with Immedica partners, contract manufacturers and external laboratories.

Job description and responsibilities

The Senior QA/RA Manager role includes

• Worldwide regulatory strategies and submission responsibility, including health authority interactions, ensuring successful approvals globally 
• Responsibility for improvement and maintenance of Technical Documentation, ensuring ongoing regulatory compliance
• Improvements of the Quality Management System with regards to compliance with applicable IVD regulations and ISO standards
• Leading the Risk Management process
• Leading the Post Market Surveillance activities
• Investigations of complaints and deviations including management of corrective and preventative actions.
• Participate in/ leading change control projects
• Establishment of Quality Agreements with contract manufacturers /service providers
• Participate in or lead audits of suppliers/service providers and internal audits
• Internal training in the area of expertise

Experience and competence

• Good industry knowledge within in-vitro diagnostic medical device, especially within Quality Management and Regulatory Affairs over the entire life cycle of a product.
• Extensive experience from in-vitro diagnostic medical device QMS, to confidently lead the ongoing improvements of our QMS
• Experience from CE-marking, 510(k) submissions, regulatory applications and registrations in international markets
• Skilled in compiling and establishing product technical documentation including risk management and product labelling 
• Experience from supplier audits, ISO:13485, 21CFR820

It is advantageous if you also have:

• Experience from working in the pharmaceutical industry (GMP/GDP) to be able to align QMS and processes in an effective way
• Experience from manufacturing in-vitro diagnostic medical device and/or from bioanalytic assays
• Experience from IVD product development

Excellent knowledge of Swedish and English, both spoken and written, is essential.

A university degree in Chemistry, Biotechnology, Biophysics or a related field is required.  To have obtained the expected experience and competence, we think you will have at least 7 years of work experience as QA/RA within the medical device area.

We are looking for an independent, responsible and proactive individual. You communicate clearly and show perseverance in reaching goals. The role calls for someone who can balance compliance requirements with operational efficiency.

You thrive in collaborative settings and enjoy taking on new challenges. Strong abilities in structuring tasks, gathering information, and analysing unfamiliar topics are highly valued. The capacity to explore, investigate and adapt quickly to new areas is essential.

How to apply

This is a full-time position based at our office at Torsplan in Stockholm. Please send your application to [email protected]. Applications are reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

About Immedica

Immedica is pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care within our focus areas: genetic & metabolic diseases, hematology & oncology and specialty care. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory and medical affairs as well as market access. Serving patients in more than 50 countries, Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need.

Immedica was founded in 2018 by investment company Impilo and buy-in management and employs today more than 150 people across Europe and the Middle East. Approximately 80 are based in the headquarters in Life City, Hagastaden, Stockholm. 

At Immedica, our core values are the foundation of our culture and the driving force behind how we operate, innovate, and collaborate. These values guide every decision we make, shaping our commitment to patients, partners, and colleagues. Open & Honest: We foster transparency, integrity, and trust through open communication. Effective: Focused on delivering excellence, we prioritize impact and quality to make a real difference in the rare disease landscape. Empowered: We encourage collaboration and ownership, creating a supportive workplace where all team member’s contributions drive innovation and growth. 

We look forward to welcoming you to the Immedica team!

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