Senior Regulatory Affairs Specialist

Job Description Summary

The Senior Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including participation on new product development teams and continued RA support through the lifecycle of the product.
The Senior RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The Senior RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. The Senior RA Specialist has developed expertise in international regulatory requirements as they apply to medical devices.

Job Description

As part of our Regulatory Affairs department, you will be responsible for the global regulatory strategy and all related activities for one or more product lines, including participation on new product development teams and continued RA support through the lifecycle of the product.

The Senior RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The Senior RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk. The Senior RA Specialist has developed expertise in international regulatory requirements as they apply to medical devices. You are also representing the company towards the authorities. The role reports directly to the Head of RA.

Main tasks:
- Establishing and maintaining registration documentation according to current regulations (Swiss Medical Devices Ordinance MEDDEV). Main contact person for all questions relating to Swiss law.
- Support for international registrations as well as representation at audits and inspections by the relevant authorities
- Review of product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communication of changes to global regions and supports preparation of global notifications as needed
- Maintanance of regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s) as needed.
- Implementation of appropriate measures in the event of non-compliance with regulations.

Requirements:
- Bachelor's degree or advanced degree in technical area such as biology, engineering or medical-related field and minimum of three years of experience, or equivalent combination of related education and experience
- Preferred minimum of two-to-four years of experience in the medical device industry with at least one year in a regulatory role
- Strong communication skills
- Fluent English written and spoken

- German language skills are desirable
- Flexibility
- Team spirit

Required Skills

Optional Skills

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Primary Work Location

CHE Wangs - Straubstrasse

Additional Locations

Work Shift