Regulatory Affairs Specialist

Vor 2 Tagen

Deutschland BioTalent Vollzeit

Job Title: Senior Regulatory Specialist

Location: Remote with travel required

About Us:

BioTalent is a leading innovator across various industries, including Medical Devices. We specialize in manufacturing both medical software and medical hardware.

Position Overview:

We are seeking a Senior Regulatory Specialist with expertise in Medical Device Regulation (MDR) and a strong understanding of Electromagnetic Compatibility (EMC) safety standards. The ideal candidate will lead regulatory activities, ensuring compliance with international regulations and standards while supporting product development.

Key Responsibilities:

  • Oversee and manage the regulatory compliance process in accordance with the European Union Medical Device Regulation (MDR), ensuring products meet all legal requirements for safety and performance.
  • Provide guidance and support on Electromagnetic Compatibility (EMC) standards and safety requirements to ensure compliance in product development and testing.
  • Collaborate with cross-functional teams, including R&D, quality assurance, and product management, to ensure regulatory requirements are integrated into product design and development processes.
  • Prepare and maintain regulatory documentation, technical files, and submission dossiers for global market entry, particularly in the EU and other international markets.
  • Stay up-to-date with global regulatory trends and changes, particularly in MDR and EMC, and provide proactive advice on potential impacts to the business.
  • Support internal audits and participate in external audits related to regulatory compliance and certifications.
  • Develop and deliver training on regulatory requirements and compliance processes across the organization.

Qualifications:

  • Previous experience within Medical Devices, with SaMD preferred but not essential.
  • Experience working across international markets.
  • In-depth knowledge of EU MDR requirements and processes, with demonstrated experience in successful regulatory submissions.
  • Strong understanding of EMC safety regulations and how they apply to medical and industrial equipment.
  • Experience working with international regulatory bodies and submission processes.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple projects simultaneously.

Why this role?

  • Be part of a growing, innovative company that's at the forefront of technology.
  • Work in a dynamic and collaborative environment with opportunities for professional development and growth.
  • Competitive compensation.

If interested in this role, please click apply or reach out directly.

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