Global Market Access Regulatory Specialist
On-siteBallerup, Capital Region, Denmark
Ballerup, Capital Region, DenmarkOn-siteFull TimeBachelors DegreeHEALTHCARELarge
Full TimeBachelors DegreeLargeHEALTHCARE
Job Summary
Conduct global product registration approvals for Medical Devices class I and IIa, managing worldwide technical file documentation for tenders and re-imbursement processes. Respond to authority inquiries regarding technical files, collect and develop documentation, and order legalizations and Free Sales Certificates. Maintain Market Access processes, work instructions, and templates while contributing to quarterly PI planning and audits. Collaborate with internal and external stakeholders across Denmark, Kazakhstan, and China to ensure successful product launches.
Required Qualifications
- Relevant master's or bachelor's degree within Medical Market Access
- Experience with world-wide Medical Device product registration approval processes
- Knowledge of EU MDR, ISO 13485 and other medical device standards and regulations
- Good stakeholder management skills
- Great collaboration and communication skills
- Ability to thrive in working in an international environment
- Attention to details and deadlines
- High-level of English skills, oral and written
Desired Qualifications
- Experience with Medical Device submissions and communication to authorities
- Experience with project management
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