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Senior Specialist Regulatory & Clinical (EMEA scope)

Senior Specialist Regulatory & Clinical (EMEA scope)

Antal Sp. z o.o.Warszawa, Polska
30+ days ago
Job description

A global medtech company with a strong footprint across EMEA is seeking an experienced professional to join its Clinical Center of Excellence , supporting end-to-end regulatory operations related to clinical investigations across multiple geographies.

Senior Specialist  Regulatory & Clinical (EMEA scope)

Key Responsibilities

  • Collaborate on the design and optimization of regulatory processes within the Clinical Center of Excellence.
  • Lead and support CA submissions and study approval pathways across EMEA countries.
  • Ensure alignment with EU MDR and evolving Competent Authority requirements.
  • Create and maintain process documentation such as work instructions, templates, and workflows.
  • Support regulatory intelligence activities to inform study design and execution.
  • Provide guidance on safety reporting requirements and contribute to process harmonization efforts.

Requirements

  • Minimum 5 years of experience in Regulatory Affairs, ideally with exposure to clinical trial submissions .
  • Strong understanding of EU MDR regulations and their practical application.
  • Experience working in international, cross-functional teams .
  • Ability to synthesize complex regulatory frameworks into clear, actionable documentation .
  • Fluent English (spoken and written); strong communication skills.
  • Project coordination or project management experience within a regulated environment is a plus.

    • Our Client Offers

  • The opportunity to contribute to international clinical excellence projects in a highly regulated and innovative environment.
  • Role within a well-established Center of Excellence with exposure to regional and global stakeholders.
  • A collaborative culture focused on quality, compliance, and patient safety .
  • Comprehensive benefits package, including :
  • Private medical care (LuxMed)
  • Prepaid card (monthly allowance)
  • Multisport card (co-financed access to sport facilities) .

    • To learn more about Antal, please visit www.antal.pl

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