Regulatory Affairs Manager - Pharma/Medical Device
Meditrial Europe Ltd. Berlin
Industry: Lifescience Industry: Pharma, Medtech, Digital Health
Employment Type: Full-timeJob Functions: Regulatory Affairs
Location: Meditrial GmbH, Berlin, Germany
Workplace: Office-based / availability to travel
The Regulatory Affairs Manager oversees the regulation process for products (Medical Device and Marketing Authorization) requiring governmental approval, including filing necessary applications and handling all government interactions. The Position will ultimately support and/or drive strategic regulatory strategies for multiple projects together with the subject matter experts.Coordinates inspections of the organization and contract facilities, and develops procedures to ensure regulatory compliance pre and post-market. The position is office-based (Rome)
Responsibilities- Management of a CTD (Electronic Common Technical Document)
- Collaborate during implementations of regulatory strategies for New MA through National/Decentralized/Centralized Procedures
- Drafting / reviewing high level clinical investigation protocols, IB's, IFUs, clinical study reports, CER, CEP, PMS, SoA, etc.
- Preparing the submissions of variations type I, II, Renewals, and Safety variations
- Manage the CMC activities (updating module III of ECTD)
- Collaborate during the Technical File (TF) creation and any updates
- Relationship with manufacturer
- Interface with all pharmaceuticals database
- Review and submission of promotional materials
- Support the management of clinical investigations
- Manage the Medical Device Post-marketing and Surveillance Medical Devices activities
- Supervise International Regulatory and Quality activities
- In addition to the above activities, the role can be asked to carry out tasks related to the belonging function or that may result from business needs
Qualification
Education: Master’s Degree in science or related field, Doctor of Medicine MD is a plus;Thorough experience in life-science field and Regulatory Affairs;
Languages: proficiency in oral and written English and German (third language is a plus);
Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);Excellent communication, planning and organizational skills;
Demonstrated ability to handle multiple competing priorities.
Preferred: experience in biostatistics
RandstadBerlin
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