
Regulatory Affairs Specialist
6 days ago
Company Overview
Thermo Fisher Scientific is a global leader in the development, manufacturing, and selling of blood test systems for clinical diagnosis and monitoring of allergy, asthma, and autoimmune diseases.
We are proud to be at the forefront of this field with 1,900 employees worldwide, 1,000 of which are in Sweden.
Job Description
This role is part of a professional and engaged Regulatory Affairs team, analysing regulatory requirements, connecting them to product documentation, and ensuring that our products conform to local regulations.
You will work closely with cross-functional teams to identify regulatory pathways and translate them into requirements to enable product registration in prioritized markets.
- Key Responsibilities:
- Collaborate with cross-functional teams to identify regulatory pathways and translate them 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 their 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.
Requirements
- A 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.
- 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.
- Excellent written and verbal communication skills in English.
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