Senior Regulatory Affairs Specialist (m/w/d)

Ihre Aufgaben

As a Senior Regulatory Affairs Specialist, you will work closely with all departments and be mainly responsible to prepare / review and maintain the technical documentation according MDR 2017/745 (EU) and preparation, review and maintenance as well as submissions for international approval.

• Responsible for the creation, review and maintenance of technical documentation
• Responsible for preparation, review and maintenance as well as supporting of submissions for international approval, for re-registration activities and for the internal communication in view of international regulatory related changes
• Support and guidance of other department forMedical Software and Cybersecurity
• Support Clinical Evaluation,Vigilance / Post-Marketing Surveillance activities
• Contribution to risk assessments
• Support in the creation and handling of Manufacturer Information (IFU, Labels, Brochure, Website, UDI)
• Support during audit (internal, external, MDSAP, etc.)
• Standard evaluation and administration in the area of expertise
• Support database entries (EUDAMED, DMIDS, GUDID, etc.)

Ihr Profil

• Appropriate Science or Engineering Degree, preferably in medical technology, or equivalent combination of education and experience in the field of technical documentation and manufacturer information
• At least 5 years of working experience with active / non-active medical devices (sterile / non-sterile)
• Fundamental understanding of the new European Medical Device Regulation (MDR 2017/745 (EU))
• Fundamental understanding of ISO medical device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601-1, IEC 62304, FDA 89 FR 7523, Cybersecurity, etc.)
• Knowledge of regulatory affairs affecting processes (e.g. product
• Ability to work under pressure and assertiveness
• Strong team player who is willing to take on and support other activities outside core expertise as required
• Ability to work flexibly across a multi-disciplinary team in jointly achieving given goals
• Able to manage multiple tasks and perform with accuracy and a high attention to detail
• Excellent verbal and written communicator; clear and concise in communications with internal and external partners
• Fluency in English and German, both written and spoken
• Time management and organizational skills
• Consistent, quality work and follows through on commitments.
• Basic computer skills (MS Office / MS Visio)