Work Schedule

Environmental Conditions

Job Description

Our focus is on developing, manufacturing, and selling blood test systems for clinical diagnosis and monitoring of allergy, asthma, and autoimmune diseases. We're the global leader in in-vitro allergy testing and the top European company for autoimmunity diagnostics. With 1,900 employees worldwide, 1,000 of which are in Sweden, we're proud to be at the forefront of this field.

You are part of a professional and engaged Regulatory Affairs team, analysing regulatory requirements, connecting this to product documentation, and ensuring that our products conform to local requirements. This role is a key player in business-critical projects, developing and implementing regulatory strategies, and working tightly together with regional Regulatory Affairs colleagues, as well as internal colleagues, to ensure compliance. You will be working cross-functionally and globally with market authorizations of diagnostic products.

What will you do?

Collaborate with cross-functional teams to identify regulatory pathways and translate into requirements to enable product registration in prioritized markets.

Plan and prepare technical documentation and submission dossiers for FDA and expedite approval of pending applications.

Monitor and interpret regulations, standards and guidelines and communicate impact.

Conduct regulatory actions such as pre-submission, dossier preparation, license renewals, change notifications, etc, to enable successful product launch and product license maintenance.

Participate in regulatory inspections and audits, ensuring all regulatory activities meet the highest standards.

Confirm and communicate regulatory strategies with our regional colleagues and keep a close collaboration to ensure nuances’ of a translated regulation is accurately interpreted and applied.

What do you need?

University degree and regulatory affairs experience within the medical device or in-vitro diagnostics industries

Ability to articulate regulatory requirements translated into business impact and opportunities and a general good understanding of regulations globally

Experience in working within an IVD/Medical Device environment (EU IVDR, ISO 13495).

Experience in preparation of regulatory documentation including pre-submissions, 510(k)s, CE-IVDR technical documentation etc.

Knowledge of specific considerations related to software and cybersecurity in a regulatory context, is an advantage.

Excellent written and verbal communication skills in English. Swedish skills is an advantage but not a requirement.

What do we offer?

We offer driven remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

We offer employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

Remote working may be an option for the right candidate!

Please apply as soon as possible, the position will be filled as soon as suitable candidate is found!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age.