Executive Regulatory Documentation
Job Description
JOB DESCRIPTION ( Regulatory Documentation)
. • Coordination with medical device consultant & will be responsible for creating documentation for certification & Compliance of (MDD)93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017•
. • Preparation of documentation for submission to INDIAN FDA•
(CDSCO, NEW DELHI) for medical device mfg. certificate approval.
. • FDA / CE / ISO 13485 - Screening of documents, compilation of dossier & drafting of letters and justifications.•
. • Internal-External audit compliances.•
. • Liasoning with drug department.•
. • Coordination with various consultants for preparation of regulatory documentation.•
. • Implementation of ISO 13485 & MDR in all Departments.•
. Training of all departments regarding documentation & regulations.
Preference given :
. Good Communication, MS office
. Candidate from medical device industry
Qualification
. Graduate/Post graduate
Job Types: Full-time, Permanent
Pay: ?18,000.00 - ?25,000.00 per month
Benefits:
• Provident Fund
Schedule:
• Day shift
Supplemental Pay:
• Performance bonus
• Yearly bonus
Ability to commute/relocate:
• Roorkee, Uttarakhand: Reliably commute or planning to relocate before starting work (Preferred)
Experience:
• QA/RA: 1 year (Preferred)
Work Location: In person
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Job Detail
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Job IdJD3520192
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IndustryNot mentioned
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Total Positions1
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Job Type:Contract
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationRoorkee, UL, IN, India
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EducationNot mentioned
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ExperienceYear