Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
About the role
- Clinical Associate managing regulatory submissions for biotech companies in Austria and Switzerland. Leading Site Activation tasks in compliance with local and international regulations.
Responsibilities
- Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
- Work and lead complex projects under general supervision.
- Serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
- Ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.
- Prepare submission documents and submit to regulatory bodies.
- Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site documents and review for completeness and accuracy.
Requirements
- B Sc degree in Health Sciences or related field
- 1 - 3 years' relevant clinical research experience, specifically in submissions.
- Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for DACH regions.
- Experience in Site Contract negotiations with DACH sites.
- Experience in medical device submissions is beneficial.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
Benefits
- No specified benefits mentioned
Job title
Job type
Experience level
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Degree requirement
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