Walk-in || Compliance Executive
Anup Ashok Ringangaonkar · Pune · onsite · Posted 43d ago
₹1.8L - ₹2.0L PA0–2 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Prepare, maintain, and update ISO 9001 / ISO 13485 and CE compliance documentation for all products and processes
- Handle Quality Management System (QMS) documentation SOPs, work instructions, technical files, and Declarations of Conformity
- Coordinate with internal teams (production, purchase, dispatch) to ensure documentation aligns with actual practices
- Prepare and maintain Technical Construction Files (TCF) / Design Dossiers for CE marking
- Liaise with Notified Bodies, certification agencies, and auditors for ISO/CE audits and renewals
- Track and ensure timely renewal of certifications, licenses, and compliance documents
- Maintain document control systems (version control, approvals, archiving) as per ISO standards
- Conduct internal audits and drive corrective/preventive action (CAPA) closure
- Ensure product labeling, instructions for use (IFU), and packaging meet CE and regulatory requirements
- Stay updated on changes in medical device regulations (MDR/EU regulations) relevant to the company's products
- Strong documentation, drafting, and record-keeping skills
- Detail-oriented with good coordination and follow-up ability
- Proficient in MS Office (Word, Excel) and document management practices
Sourced from naukri
Skills
Compliance ManagementAudit CompliancecomplianceQC