Jobbeschreibung

Positionsnummer / Reference Number

PA2202108092020

Position / Job Title

Senior Regulatory Affairs Manager

Aufgaben / Tasks

- Ensuring that regulatory requirements for the approval of medical devices are met during the product development process
- Support and consulting for research & development and brand management in the interpretation of regulatory requirements throughout the entire lifecycle of the products and ensuring that the technical documentation of the products complies with the respective requirements for medical devices
- Communication of new regulatory approval requirements to research & development as well as brand mangement and support in the implementation thereof
- Participation in interdisciplinary product development teams
- Assessment of products with regard to their risk potential
- Responsibility for the regulatory content of product-related information and its release
- Conducting conformity assessment procedures for the products and initiating the preparation of the declaration of conformity
- Support of international product registration
- Support in the preparation and execution of audits
- Support in continuing improvement of quality procedures and regulatory processes

Qualifikationen / Qualifications

- Scientific, medical or engineering background, or corresponding industry experience
- 8+ years experience in regulatory affairs and in international approvals in the field of medical devices or pharmaceuticals
- Experience in quality management and / or product development is an advantage
- TÜV certified Regulatory Manager or equivalent education
- Knowledge of MDD 93/42/EEC as well as MDR 2017/745 (product classification, definition of applicable standards, conformity assessment procedures)
- Experience in working in interdisciplinary teams
- Excellent MS-Office knowledge, experience in handling document control and ERP systems (e.g. SAP)
- German and English proficiency written and spoken, additional languages are an advantage

Weitere Informationen / Further Information

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