Country: Hungary
Functional area: Regulatory Affairs

On behalf of our global pharmaceutical client, we are seeking proactive and detail-oriented Medical Safety Compliance Specialists, who will be the new members of the company's Regulatory Team. In this role, you will ensure that medical products remain compliant with regulatory requirements throughout their lifecycle. You will work cross-functionally, provide subject matter expertise, and play a critical role in shaping regulatory strategy and post-market quality processes.

Responsibilities:

  • Prepare and coordinate regulatory submission dossiers for both newly developed and existing products.
  • Organize, update, and manage documentation for submissions, license renewals, and annual registrations.
  • Advise on strategic adjustments to labeling, manufacturing processes, marketing activities, and clinical protocols to maintain regulatory compliance.
  • Oversee and enhance systems for tracking and controlling regulatory documentation.
  • Stay informed on regulatory developments and engage with regulatory authorities when required.
  • Contribute to post-market surveillance (PMS) activities by reviewing scientific literature and analyzing competitor recalls.
  • Offer guidance and mentorship to less experienced colleagues, serving as a subject matter resource.

Requirements:

  • MD or Life Sciences degree with at least 3 years’ experience in regulatory affairs or a related field.
  • Strong knowledge of regulatory processes, with a commitment to staying current on evolving requirements.
  • Excellent communication and teamwork skills, able to collaborate across diverse functions.
  • Proficient in digital tools, especially Google Suite and AI applications.
  • Fluent in English, with strong analytical, problem-solving, and solution-oriented abilities.
  • Confident, detail-focused, and adaptable, with occasional travel availability (5–10% annually).

Should you be interested in the details of this vacancy please upload your CV and we will get in touch with you for professional discussion.

On behalf of our global pharmaceutical client, we are seeking proactive and detail-oriented Medical Safety Compliance Specialists, who will be the new members of the company’s Regulatory Team. In this role, you will ensure that medical products remain compliant with regulatory requirements throughout their lifecycle. You will work cross-functionally, provide subject matter expertise, and play a critical role in shaping regulatory strategy and post-market quality processes.

Responsibilities:

  • Prepare and coordinate regulatory submission dossiers for both newly developed and existing products.
  • Organize, update, and manage documentation for submissions, license renewals, and annual registrations.
  • Advise on strategic adjustments to labeling, manufacturing processes, marketing activities, and clinical protocols to maintain regulatory compliance.
  • Oversee and enhance systems for tracking and controlling regulatory documentation.
  • Stay informed on regulatory developments and engage with regulatory authorities when required.
  • Contribute to post-market surveillance (PMS) activities by reviewing scientific literature and analyzing competitor recalls.
  • Offer guidance and mentorship to less experienced colleagues, serving as a subject matter resource.

Requirements:

  • MD or Life Sciences degree with at least 3 years’ experience in regulatory affairs or a related field.
  • Strong knowledge of regulatory processes, with a commitment to staying current on evolving requirements.
  • Excellent communication and teamwork skills, able to collaborate across diverse functions.
  • Proficient in digital tools, especially Google Suite and AI applications.
  • Fluent in English, with strong analytical, problem-solving, and solution-oriented abilities.
  • Confident, detail-focused, and adaptable, with occasional travel availability (5–10% annually).

Should you be interested in the details of this vacancy please upload your CV and we will get in touch with you for professional discussion.