Regulatory Affairs Consultant

3 days ago


Stockholm, Stockholm, Sweden Adxto AB Full time

Ready to make an impact in regulatory affairs?We are looking for a Regulatory Affairs Consultant for a consulting assignment with a client in the medical device and pharmaceutical industry. The consultant will play a key role in regulatory project clean-up and master data management, ensuring compliance with evolving regulations and supporting regulatory transitions.

Key Responsibilities:

  • Collaborate with cross-functional teams and external partners to gather regulatory intelligence for local MDR registrations and regulatory updates.
  • Facilitate the transition of Legal Manufacturer status for compliance purposes.
  • Compile and manage registration dossiers for multiple countries and coordinate with distributors until submission.
  • Handle legalization and apostille processes for regulatory submissions.
  • Assist in drafting regulatory submission documents for non-EU markets.
  • Manage artwork requests to ensure compliance with regulatory updates.
  • Ensure SPOR/PMS product master data cleansing, verifying and updating compliance-related information.
  • Complete missing PMS master data ahead of regulatory deadlines.
  • Verify and compile product master data for regulatory databases.
  • Draft SPOR SOPs and support regulatory data clean-up initiatives.
  • Support Veeva RIM activities and other regulatory documentation tasks.

Who We Are Looking For:

  • Proven experience in Regulatory Affairs within Medical Devices and/or Pharmaceuticals.
  • Strong understanding of MDR regulations and product master data compliance.
  • Experience with Veeva RIM and SPOR/PMS data management is a plus.
  • Ability to manage cross-functional collaborations and external partnerships.
  • Excellent organizational skills with strong attention to detail.
  • Experience in dossier compilation and regulatory submission processes.
  • Self-motivated and able to work independently in a consulting capacity.
  • Fluent in English, with strong communication skills in both written and spoken form.

This consulting assignment offers an exciting opportunity to work with a leading company in the pharmaceutical industry, in a dynamic and supportive environment. You'll be at the heart of critical regulatory compliance projects, making a real impact while applying your expertise to drive compliance and innovation in a rapidly evolving industry.

Location: Stockholm
Start:By agreement
Employment type:Consulting assignment, 100%

Interested? Apply now, as we are reviewing candidates continuously

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