- 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.)
Senior Regulatory Affairs Specialist (m/w/d)
DMT-Germany - Wessling
Vollzeit
Festanstellung
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.
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
About us
Dornier MedTech is a medical device company headquartered near Munich, Germany, and a wholly owned subsidiary of Advanced MedTech. As a pioneer in the field of urology, Dornier is one of the most trusted names in the industry.
With the introduction of several breakthrough technologies and revolutionary therapies in recent years, we continue to drive medical performance and pioneer innovation in urology. As the world's first MDR-certified integrated urology company and one of the founders of the Urology Care Foundation (formerly known as the American Foundation for Urologic Diseases), we pride ourselves on holding ourselves to the highest standards of patient safety and product efficacy.
Today, we are setting new standards in digital urology to provide holistic care to patients seeking treatment and support the community on their road to recovery, both online and on-site.
Trusted by thousands of physicians and patients, Dornier is committed to supporting our urological communities worldwide.