Regulatory Affairs & Quality Specialist
Skills
ASQData PrivacyEnglishISO StandardsMedical DevicesPlaysQuality Management
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- 3+ years of experience in quality management systems
- Knowledge of ISO 13485 MDSAP and EMDR requirements
- Proficiency in MS Office Google Suite and Visio or similar workflow tools
- Experience in the IT and/or medical device field
- Process mapping and creation
- Autonomy and self-motivation
- Strong collaboration skills
- Problem-solving abilities
- Continuous learning mindset
- Effective oral and written English communication skills
- Bachelor’s degree in business regulatory management quality management or related field
- Relevant industry training or certifications such as RAPS RAC ASQ CQA or similar
Nice to have
- Autonomous
- Self-motivated
- Collaborative
- Problem-solver
- Continuous learner
Day to day
- Maintain and improve key quality certifications and regulatory compliance across the management system.
- Manage CAPAs QMS documentation audits training materials metrics and process improvements to strengthen quality operations.
- Collaborate with cross-functional teams to integrate regulatory requirements update SOPs support supplier processes and handle EUDAMED renewals.
Hiring process
- Applicants may be required to complete an online technical assessment
- Applicants may be required to complete a personality assessment as part of the application