**Work Schedule** **Environmental Conditions** **Job Description** Are you ready to make a significant impact in the field of clinical diagnostics? We are excited to welcome a professional and skilled Regulatory Affairs Manager to our team. Our company is a global leader in in-vitro allergy testing and the top European company for autoimmunity diagnostics. With 1,900 employees worldwide, including 1,000 in Sweden, we are at the forefront of developing, manufacturing, and selling blood test systems for the diagnosis and monitoring of allergy, asthma, and autoimmune diseases. **About the Role:** As a key member of our professional and engaged Regulatory Affairs team, you will analyze regulatory requirements, connect them to product documentation, and ensure our products meet local regulations. You will play a crucial role in business-critical projects, developing and implementing regulatory strategies, and collaborating closely with regional Regulatory Affairs colleagues and internal teams to ensure compliance. This role involves working cross-functionally and globally to secure market authorizations for our diagnostic products. **Key Responsibilities:** + Investigate regulatory pathways and translate them into requirements for product registration in prioritized markets. + Plan and prepare technical documentation and submission dossiers to expedite approvals of pending applications. + Monitor and interpret regulations, standards, and guidelines, and communicate their impact. + Conduct regulatory actions such as pre-submission, dossier preparation, license renewals, and change notifications to enable successful product launches and license maintenance. + Participate in regulatory inspections and audits, ensuring all regulatory activities meet the highest standards. + Confirm and communicate regulatory strategies with regional colleagues, ensuring accurate interpretation and application of regulations. **Qualifications:** + University degree or equivalent experience in regulatory affairs within the medical device or in-vitro diagnostics industries. + Ability to articulate regulatory requirements and translate them into business opportunities, with a solid understanding of global regulations. + Experience working within an IVD/Medical Device environment (EU IVDR, ISO 13485) for risk class A and B products (IVD-R). + Proven experience in preparing regulatory documentation (such as FDA pre-submissions, 510(k)s, IVDR technical documentation) and communicating with regulatory authorities/notified bodies. + Knowledge of software and cybersecurity considerations in a regulatory context is an advantage. + Curiosity to learn about our products, their applications, and how to apply regulatory requirements to our portfolio. + Excellent written and verbal communication skills in English, with the ability to adapt communication styles to different audiences. Swedish skills are an advantage but not required. **What We Offer:** Competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits. Employment with an innovative, forward-thinking organization, offering outstanding career and development prospects. Remote working options may be available for the right candidate. Apply now and become a part of our success story! We are eager to fill this position as soon as we find the right candidate. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.