Senior / Principal Regulatory Affairs Specialist (m/f/x) | Zug (CH) | Pharma & Medical Devices
In this role you will perform all necessary regulatory activities for medicinal products in the DACH region (DE, AT, & CH) + Liechtenstein. You will establishe, develop and manage the Swiss Authorized Representative office on behalf of the mother company. You will ensure timely notification of all medicinal products / medical devices to Swissmedic in compliance with national legislation. Develop processes to ensure that all products in the DACH region are maintained in compliance throughout the product lifecycle. Partnering closely with the commercial organisation in the region, acts as the primary point of contact for all medicinal products in the DACH region.
What will your activities as "Senior / Principal Regulatory Affairs Specialist" involve?
Managing the Swiss Authorized Representative office
Performing Health Authority notifications
Reviewing and approving advertising and promotional materials
Conducting Change evaluations for impact to the DACH region
Working with distributors of medical devices & medicinal products
Managing materiovigilance activities
Verifying packaging and labelling artwork meets local requirements
Supporting Field Safety Corrective Actions
Staying current on national and European legislation
Participating in regulatory policy and intelligence activities
Supporting regional/global projects as applicable
What does the position as "Senior / Principal Regulatory Affairs Specialist" offer you?
Salary: very competitive compensation package
Contract type: unlimited
Vacation: 30 days / year
Working time: 40 hours / week
Accessibility: Very good transport connections by public transport; sufficient parking spaces available
Start date: At the next possible date
What requirements should you bring as "Senior / Principal Regulatory Affairs Specialist"?
Bachelor's degree in science, engineering, law, pharmacy or another related field
Advanced degree preferred (MS, PharmD, Ph.D. or equivalent)
At least 5 years of experience in regulatory affairs, quality or compliance with Medicinal Products in Europe
Knowledge of legislation for Medical devices (93/42/EEC) and (EU 2017/745)
Knowledge of Swiss medical devices ordinance
Capability to react quickly to changes in the regulatory environment
Self-motivated, detail-oriented and capable of working independently
Demonstrated ability in analytical reasoning and critical thinking skills
Fluent written and spoken English and German
Experience working in cross-functional teams
Information about our customer:
Our client is a leading global healthcare company. In addition to contact lenses and surgical instruments, the company also produces pharmaceuticals and is uniquely positioned internationally with this range of products. The company employs more than 12,000 people worldwide, and more than 700 at the second largest company location in Berlin.
Does this position appeal to you? Then you should apply right away! If you would like to receive further or alternative positions, I would also be pleased to receive your application!
I look forward to your application!