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 for Medical 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
• development, risk management, project management, Vigilance, PMS, CAPA, Complaints, etc.)
• 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)

Warum wir?

• Personal induction plan and comprehensive onboarding
• Flexible working hours
• 30 days of holiday
• interesting tasks in a dynamic, international environment
• Continuous training and development
• Flat hierarchies
• Attractive canteen
• Free coffee, tea and water
• Employee events
• Charging stations for electric cars
• Accident insurance
• Employer contribution to VWL
• Employee fund with various allowances and subsidies
• Free language courses

Über uns

Dornier MedTech ist ein Unternehmen für Medizinprodukte mit Hauptsitz in der Nähe von München, Deutschland, und eine hundertprozentige Tochtergesellschaft von Advanced MedTech. Als Pionier auf dem Gebiet der Urologie ist Dornier einer der vertrauenswürdigsten Namen in der Branche.

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