Regulatory Affairs Specialist
New
ItalyFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum of 1-2 years experience in creating and managing international regulatory submissions for Medical Devices (Class I & II preferred) or more than 5 years in the medical device industry
- Required Skills
- Project Management
Requirements
- Degree in medical, science, engineering, or regulatory discipline
- 1-2 years experience in international regulatory submissions for Medical Devices
- 5+ years in medical device industry or GMP environment
- Experience with Class I and Class II hardware devices
- Global registration experience
- Project management experience
- Proficiency in Microsoft Office suite
- Analytical and problem-solving skills
- Excellent English communication skills
Responsibilities
- Provide regulatory input to new product development and product lifecycle planning
- Generate documentation relating to product development, manufacturing, and quality control
- Ensure compliance with 21 CFR 820, MDR, ISO 13485
- Collaborate with product development, clinical, and marketing teams
- Review clinical evaluation reports, risk analysis, FMEA, and labeling
- Assist with document control and regulatory file maintenance
- Assess documentation for regulatory submission filing
- Monitor applications under regulatory review and communicate progress
- Provide regulatory input for recalls and CAPAs
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