Requirements

• Degree in engineering or life sciences preferred, but other degrees may be considered
• Professional experience in regulatory affairs or regulatory compliance in the medical device field (e.g.: knowledge of MDR,
• ISO13485, CFR 21, MDCG guidelines). Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
• Excellent English and proficient German written and verbal communication skills
• Ability to communicate with all stakeholders
• Independent, structured and pragmatic working style
• Persuasive power

Activities

You are interested in Regulatory Affairs, Quality Management and in medical devices? As QM Associate in our Regulatory Affairs team you will interact with Rhyk internal departments and partners internationally and Regulatory Agencies from Europe/Brasil/all over the world. In a cross-functional team you will be involved in the development of various Rhyk Medical products (and be responsible for establishing the regulatory strategy). You will interpret regulatory requirements and implement them in projects.

Your duties include:

• Collaboration on the creation, updating and review of the Technical documentation before CE marking a new/changed medical device
• Evaluate and follow up design changes during the development and implementation
• Participation in the documentation of product changes – change management
• Discuss regulatory topics with R&D colleagues and other departments
• Establish global regulatory strategies in collaboration with local partners and Rhyk’s management team.
• Compile regulatory submissions to be send to authorities, notified body and other authorities
• Monitor & investigate regulatory requirements in pre-defined countries
• Partitipation and preparation of regulatory audits and follow up improvement opportunities
• Regular market monitoring and preparation of PMS/PSU reports
• Oversee CAPA and post market activities
• Maintain the already certified QMS systems