Senior Regulatory Affairs Specialist (m/w/d)

Unternehmen : Dornier Medtech

Auftragstyp : Vollzeit

Weßling, Germany

Arbeitsbeschreibung - 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
English (C1) and German (B1) language skills, 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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