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Regulatory Analyst

ConnectinPro

Last Updated: 4/08/21

Job Description

Dear Job Seekers,

Our Client is Hiring for:

Job Title: Regulatory Analyst

Skills:

  • 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

Preferred Skills:

  • 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

Location: Nagpur



Company Details


ConnectinPro

Hyderabad, Telangana, India

ConnectinPro is a full service consultancy company offering recruitment , staffing & manpower consulting services.  Experience : The team has more than 5 years combined experience working with start-up microfinance institutions, transforming, growing and established entities in the recruitment services sector. Vision : Transcend as a local leading professional services firm f...