RA Specialist.
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Key Responsibilities:
Regulatory Strategy: Develop strategies for market access and regulatory approvals.
Regulatory Compliance: Ensure medical devices comply with EU MDR (2017/745) and other relevant regulations.
Technical Documentation: Prepare and maintain Technical Files
Regulatory Submissions: Handle CE Marking Notified Body interactions and EU registrations.
Post-Market Surveillance: Adverse events vigilance reporting and Periodic Safety Update Reports (PSURs).
Labeling & UDI Compliance: Ensure product labeling and Unique Device Identification (UDI) requirements are met.
Quality System Support: Work with ISO 13485 and Quality Management Systems (QMS).
Cross-functional Collaboration: Coordinate with R&D Quality and Manufacturing teams for regulatory compliance.
Qualifications & Skills:
Education: Bachelors or Masters degree in Biomedical Engineering Life Sciences Pharmacy or Regulatory Affairs.
Experience: 3-5 years in medical device regulatory affairs preferably with EU MDR and NPD experience and have worked in OEM (preferred)
Knowledge:
Strong understanding of EU MDR ISO 13485 and CE Marking processes.
Knowledge on LCM of Medical Devices.
Ensure effective communication throughout RA
Knowledge on Dossier creation compilation and review regulatory strategy and market launch of medical devices.
Communication: Excellent written and verbal communication skills for Notified Body interactions.
Attention to Detail: Ability to analyze and interpret regulatory guidelines
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
