Regulatory Affairs Specialist

Regulatory Affairs Specialist

Candidates from EU who would like to relocate to Switzerland are welcomed

Experis is the global leader in professional resourcing and project-based workforce solutions.

On behalf of our client, a pharmaceutical company in Zuchwil, we are looking for a Regularity Affairs Specialist to join the team in one of well known companies in Zuchwil.

Location: Zuchwil

Duration: 12 months

Start date: ASAP

Remote work: 2 day of home office

Your responsibilities:

• Prepare and/or assist in creation of regulatory documentation for medical devices, including IDE, 510(k), PMA, Technical Files, Design Dossier, and Technical Documentation files for submission to regional Health authorities per FDA, MDD and MDR requirements.
• Provide support in preparation, writing and submission of global registration activities requirements.
• Incumbent knows, understands, incorporates and follows all applicable laws and regulations relating to companies business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
• Review and approve changes with Product Lifecycle Management System to devices, design, packaging and labelling for Notified Body, FDA, and Global impact.
• Review product labelling and product support information.
• Capture project specific metrics and present progress reports to Program Management & other stakeholders

You bring:

• Knowledge of S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance's and standards
• Minimum 1- 2 years of prior regulatory affairs or experience in medical devices
• Ability to author Regulatory deliverables independently
• Proficient with MS Office applications such as MS Word, PowerPoint, Excel
• Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives.
• Knowledge of orthopaedic implants a plus
• Familiarity with electronic submission preparation a plus
• Excellent written and oral communication skills
• Fluent in English

Don't hesitate and send us your CV and testimonials today through the link in the advert.

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Martyna Slosarczyk