Regulatory Affairs Specialist For Medical Devices

1 week ago

Ahmedabad, India MJ Surgical Full time

We are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as per EU MDR. 5. Have Knowledge About QMS (Quality Management Systems). 6. Reporting To Regulatory Authorities. 7. Conducting Internal Quality Audits. 8. Have Knowledge of European CE (MDD & MDR). 9. Have Knowledge of USFDA 510K. Skill: 1. Documentation Handling. 2. Written & Verbal Communicate Skill. 3. Have Good Knowledge Of Computer And MS Office. Education Qualification of Candidate: B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science Discipline with Training in Medical Devices in Regulatory Affairs. Experience: Medical Devices: 3-5 years (Required) Salary Criteria: ₹30,000.00 - ₹80,000.00 per month - Depends on Interview Benefits: Leave encashment Provident Fund Yearly bonus

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as...

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA. 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Design & Development and Risk Management Files as...

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments)Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

  • Regulatory Affairs Specialist For Medical Devices

    2 weeks ago

    ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

  • Regulatory Affairs Specialist For Medical Devices

    2 weeks ago

    Ahmedabad, India MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, Gujarat, India MJ Surgical Full time ₹ 7,20,000 - ₹ 28,80,000 per year

    We are HiringRegulatory Affairs Specialist For Medical Devices(OrthopedicImplants And Instruments)Role & Responsibilities:Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.Work On Technical Master File.Work On CERs (Clinical Evaluation Report) As Per EU MDR.Work on Design & Development and Risk Management Files as per EU MDR.Have...

  • Regulatory Affairs Specialist For Medical Devices

    1 week ago

    Ahmedabad, Gujarat, India, Gujarat MJ Surgical Full time

    We are Hiring Regulatory Affairs Specialist For Medical Devices (OrthopedicImplants And Instruments) Role & Responsibilities:1. Documents Preparation for ISO13485, CE Certificate (As Per EU MDR), USFDA.2. Work On Technical Master File.3. Work On CERs (Clinical Evaluation Report) As Per EU MDR.4. Work on Design & Development and Risk Management Files as per...

  • Regulatory Affairs Executive

    7 days ago

    Ahmedabad, India MJ SURGICAL Full time

    We are Hiring QA/Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants and Instruments) **Role & Responsibilities**: 1. Documents preparation for ISO13485, CE Certificate (As per EU MDR). 2. Work on technical master file. 3. Work on CERs (clinical evaluation report) as per EU MDR. 4. Have knowledge about QMS (quality management systems). 5....