QA & RA Officer Medical Devices

About Gymna International
Gymna is a leading player in the medical and physiotherapy industry. We provide high-quality equipment, innovative solutions, and excellent service to healthcare professionals. Our mission is to support therapists worldwide in enhancing the quality of life for their patients. To strengthen our quality team, we are looking for a QA & RA Officer Medical Devices.

Your Responsibilities

QA:

• Manage and improve the Quality Management System (QMS) in collaboration with stakeholders
• Maintain compliance of the organisation, processes and products to relevant laws and regulations (ISO13485, MDSAP, MDD, MDR)
• Follow-up of complaints and CAPA’s
• Perform internal audits and post-market surveillance activities
• Participate in risk management meetings
• Participate in external audits and inspections

RA:

• Prepare regulatory submissions and license renewals across the world
• Manage distributor assortment based on registration evidence
• Maintain library of relevant standards, laws and guidelines
• Determine regulatory requirements for projects and ensure product compliance
• Provide regulatory expertise throughout the company

Who Are You? 

• Bachelor’s or higher graduate degree preferably in a technical or science related field (e.g. Life sciences)
• Minimum 3 years of experience in Quality Assurance and/or Regulatory Affairs in the medical device or pharmaceutical industry
• Experience in Medical Devices Regulations (MDR)
• Practical knowledge of ISO 13485: 2016; knowledge of MDSAP is a plus
• Experience in managing and submitting registrations of product documentation to regulatory authorities; knowledge of international regulatory requirements would be a plus
• You have an eye for detail and are interested in technical writing
• You are a good communicator, within the company and towards relevant authorities.
• Fluent in English
• You are able to find a good balance between critical mindset and practical approach
• You are eager to learn about the medical industry and its regulations
• You have excellent interpersonal skills and are well-organized, rigorous, autonomous and flexible

What Do We Offer?

• A versatile support role within an internationally operating company.
• An informal work environment within a team focused on collaboration and personal development.
• Room for your own initiative and ideas.
• A competitive salary and excellent secondary benefits.
• Internal/external training to help you further develop in your field.
• An attractive salary package that matches your experience and expertise.
• 6 additional ADV days on top of your statutory vacation days.
• Bike leasing, hospitalization and group insurance.
• A workplace in a traffic-free area.

How to Apply:

Are you our new positive, enthusiastic colleague ready to make a difference? Send your motivation letter and CV to marjan.vanheusden@gymna-uniphy.com.

We look forward to your application!

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