Industry: Lifescience Industry: Pharma, Medtech, Digital Health
Employment Type: Full-time
Job 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
Preparing the submissions of variations type I, II, Renewals, and Safety variations
Manage the CMC activities (updating module III of ECTD)
Collaborate during the Management of Recall
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
Notify the new Food Supplements and any changes to Ministry of Health
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.
Karrierestufe
Management
Beschäftigungsverhältnis
Zeitarbeit
Tätigkeitsbereich
Rechtswesen
Branchen
Krankenhäuser und Gesundheitseinrichtungen
Mit einer Empfehlung lassen sich Ihre Chancen auf ein Vorstellungsgespräch bei Meditrial verdoppeln.