In-Vitro Diagnostic Specialist

6 days ago


Uppsala, Uppsala, Sweden Thermo Fisher Scientific Full time

Job Description

The Regulatory Affairs Manager will play a key role in ensuring that our products conform to local regulations and laws. This involves collaborating with cross-functional teams to identify regulatory pathways and translating them into requirements to enable product registration in prioritized markets.

Responsibilities

  1. Key Responsibilities:
  2. Collaborate with cross-functional teams to identify regulatory pathways and translate them into requirements to enable product registration in prioritized markets.
  3. Plan and prepare technical documentation and submission dossiers for FDA and expedite approval of pending applications.
  4. Monitor and interpret regulations, standards, and guidelines and communicate their impact.
  5. Conduct regulatory actions such as pre-submission, dossier preparation, license renewals, change notifications, etc., to enable successful product launch and product license maintenance.
  6. 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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