Regulatory Affairs Consultant
3 days ago
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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