Key skills:
Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
Desired Candidate Profile
• Implementation and improvement in Quality Management System as per ISO 13485:2016.
• Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.
• Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval.
• Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance.
• Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch.
• Giving line clearance before starting the New Batch.
• Review and analysis of Environmental Monitoring plan to monitor environmental condition and hygiene of Personnel working in manufacturing areas and other controlled areas.
• Experience of CE, ISO 13485:2016 and GMP Inspections.
• Experience of Risk Management as per ISO 14971
• Experience of Design & development file as per ISO 13485:2016
• Knowledge of Post Market Surveillance and Post Market Clinical Follow Up, Product recall-
Handling and handling market complaints as per SOP and maintaining its records.
Education- UG: B Tech in Mechanical, BE – Bio Medical, B. Pharma, B. Tech Medical Science
#JobOpening #Hiring #JobSearch #NowHiring #CareerOpportunity #Employment #JobOpportunity #JobListing #JobPosting #JobAlert #recruitment If interested can forward your updated resumes on hr5@tasolutions.in and can directly contact us on 8427933492 also can provide our reference to your friends and colleagues.
Job Description
Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries
Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.
Key skills:
Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
Desired Candidate Profile
Minimum B. Tech in Mechanical, Bio Medical, B. Pharma, B. Tech Bio Medical Science or a science discipline
· 2+ years of experience implementing test strategies, test plans and test cases for validation and verification in FDA-compliant medical device industry
· Demonstrated success in a start-up, entrepreneurial work environment
· Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
· 2+ years of experience in verification/validation of products incorporating scalable data acquisition, processing, management, and reporting functionalities.
· 2 or more years of experience with QMS implementation that complies with, MDD /93/42/EEC, ISO 13485 and ISO 14971 standards.
· Lead role (administrative or technical) in one or more FDA submissions for approval of a medical device
· Project management skills and proficiency and analysing and interpreting test data
Education-
UG: B Tech in Mechanical, Bio Medical, B. Pharma, B. Tech Medical Science or a Science
#JobOpening #Hiring #JobSearch #NowHiring #CareerOpportunity #Employment #JobOpportunity #JobListing #JobPosting #JobAlert #recruitment If interested can forward your updated resumes on hr5@tasolutions.in and can directly contact us on 8427933492 also can provide our reference to your friends and colleagues.
Designation: Sales Manager
Experience: 5-10 Years
Salary range : 6-8 LPA
Location : Bangalore
Qualification: Diploma and above
Gender Preference: Male
Responsibilities :-
Lead, manage, and motivate a team of sales executives to achieve sales targets
Develop and execute sales strategies to drive revenue growth and market expansion
Conduct sales performance analysis, forecasting, and territory planning
Collaborate with cross-functional teams, including marketing, customer support, and product development
Provide training, coaching, and product knowledge to sales team
Build and maintain strong relationships with key customers, including surgeons, hospital administrators, and purchasing decision-makers
Stay up-to-date with industry trends, competitor activity, and new product developments
Manage sales budgets, expenses, and resources
Skills Required
5+ years of experience in medical sales management, preferably in surgical equipment
Proven track record of sales and team management
Strong knowledge of medical equipment field and laparoscopy procedures and equipment
#JobOpening #Hiring #JobSearch #NowHiring #CareerOpportunity #Employment #JobOpportunity #JobListing #JobPosting #JobAlert #recruitmentIf interested can forward your updated resumes on hr5@tasolutions.in and can directly contact us on 8427933492 also can provide our reference to your friends and colleagues.
