This site uses cookies. To find out more, see our Cookies Policy

Sr Specialist RAQA in Gurugram at Stryker Corporation

Date Posted: 4/11/2019

Job Snapshot

Job Description

Insert detailed job description here.

Under general supervision of the RA Manager or  RA Department Manager.

  • Handling of Complaints: Entering each STRYKER INDIA complaint into Trackwise sytem thereby generating PI, Following up with physician for the complaint product (as is directed by division), Sending report to physician and closure of complaint.
  • Return of Complaint products: Ensuring the complaint products are returned back, taking UMD kits from Warehouse, packing each complaint product into UMD kits, coordinating with Warehouse for sending back the complaint products
  • Product Hold/Recall/Withdrawal: Keeping a check on product holds/recalls initiated on STRYKER INDIA products, In case any recall or withdrawal for STRYKER INDIA products is undertaken in India preparing documents for intimation of the same.
  • Preparing, submissions and follow up of all new products as per the priority list defined by the Stryker RA & Commercial Teams. *
  • All the communication deemed necessary with the CDSCO/DCGI authorities to complete the process of getting Registration Certificate/Import License. *
  • Adverse Event Reporting: Preparing documents for reporting of worldwide adverse events reported for any STRYKER INDIA products to CDSCO*
  • While performing above services, the RA Specialist shall maintain complete records including but not limited to copies of all communications with authorities, copy of application, follow up communications etc.*
  • Evaluates and approves proposed changes to products and controlled documents; develops, approves, and implements local regulatory action plans based on the changes.  Organizes and maintains RA files.*
  • Reviews and approves labeling (Instructions for Use, labels, promotional materials) for compliance to:  standards, guidelines, regulations, and regulatory approvals/clearances.*    
  • Provides regulatory support to other Stryker personnel to facilitate cross-divisional leverage.
  • Analyzes existing systems and procedures, recommends solutions/improvements, and writes Work Instructions, SOPs, and SLPs as needed to support departmental functions and Stryker’s Quality System.  Prepares and delivers training programs to the department and other functional groups to ensure compliance.
  • Uses existing project management tools, and develops/implements new tools as needed.
  • Adverse Event Reporting: Preparing documents for reporting of worldwide adverse events reported for any STRYKER INDIA products to CDSCO

Work From Home: No

Travel Percentage: None

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team