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Regulatory Affairs Consultant
Eingestellt von Darwin Recruitment
Gesuchte Skills: Consultant, Support
Projektbeschreibung
REGULATORY AFFAIRS CONSULTANT
ROLES & RESPONSIBILITIES
- Manage complex activities and consulting projects
- Manage Regulatory Affairs activities in preparation, maintenance and submission of STED/Technical Files and FDA 510(k) clearances
- Provide intelligence regulatory strategy for developing and improvement of products
- Perform reviews and gap assessments of risk management documentation according to EN ISO 14971:2012 with respect to regulatory requirements
- Support interaction activities with notified bodies and government agencies
YOUR BACKGROUND
- Master or Bachlor degree in Life Sciences, law or equivalent
- Strong knowledge in Regulatory Affairs, including: European Medical Device Regulations, especially Council Directive 93/42/EEC and ISO 13485 standard
- Experienced with Risk Management documentation for medical devices according to EN ISO 14971:2012
- Experienced with Technical File/Design Dossier documentation
- Proven ability of interpreting legislation and impact to meet commercial needs
ROLES & RESPONSIBILITIES
- Manage complex activities and consulting projects
- Manage Regulatory Affairs activities in preparation, maintenance and submission of STED/Technical Files and FDA 510(k) clearances
- Provide intelligence regulatory strategy for developing and improvement of products
- Perform reviews and gap assessments of risk management documentation according to EN ISO 14971:2012 with respect to regulatory requirements
- Support interaction activities with notified bodies and government agencies
YOUR BACKGROUND
- Master or Bachlor degree in Life Sciences, law or equivalent
- Strong knowledge in Regulatory Affairs, including: European Medical Device Regulations, especially Council Directive 93/42/EEC and ISO 13485 standard
- Experienced with Risk Management documentation for medical devices according to EN ISO 14971:2012
- Experienced with Technical File/Design Dossier documentation
- Proven ability of interpreting legislation and impact to meet commercial needs
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges