Beschreibung
Regulatory Affairs Specialist (m/f/d)
Reference: -en
Start: 01/21
Duration: 12 MM
Main tasks:
- Identify, create, update, review and/or approve reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Instructions for use, labeling and Declaration of Conformity.
- As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.
- Identify and adhere to policies, procedures and work instructions which support technical documentation activities
- Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials
- Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan
- Support for routing and implementation of the remediated documents in PLM systems
- Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required
- Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned
- Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
Main qualifications
- Profound regulatory experience in European Medical device industry. Proficient knowledge of MDR strongly preferred
- Strong knowledge of ISO 13485
- Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) )
- Reasonable knowledge of FDA requirements and possibly registration requirements in further global markets;
- Strong understanding of Risk Management process, label and labeling, change management is desired
- Proven exceptional written and oral communication skills in English
- Bachelor's or Master’s Degree in engineering or life sciences is required
Main advantages:
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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