Dear Job Seekers,
Our Client is Hiring for:
Job Title: Regulatory Analyst
- Preparation of RMF, Technical Files, annual/periodic documents as per EUMDR and US FDA regulations.
- Perform the gap assessment and remediation against regulatory documents and standard documents.
- Classification of medical devices based on USFDA, TPD, MDD, PAL & other National/Regional regulations
- Authors, edits, coordinates, assembles, and prepares submission documents
- Assist on internal regulatory audits and regulatory reporting.
- preparation of regulatory assessment on proposed changes to marketed devices.
- Preparation and compilation of technical documents for regulatory submission, DMR/DHF documents
- Successful track record of authoring/submission/approval of Class I/II/III medical devices
- Experienced in preparing and submitting Technical files to Regulatory Agencies and/or Notified Bodies
- Ability to work in a timeline driven environment
- Direct experience with standards and certifications for global markets
- Knowledge on Part 820, Part 11, ISO 13485, MDR
Experience: 3 to 15 Years
Salary: As per the Company Standards