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 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 inBio-Medical Engineering / Science Discipline with Training in Medical Devices inRegulatory Affairs.Experience: Medical Devices: 3-5 years (Required)Salary Criteria: ₹30,000.00 - ₹80,000.00 per month - Depends on InterviewBenefits:Leave encashmentProvident FundYearly 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 (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

    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 Specialist for Medical Devices

    2 weeks ago

    ahmedabad, India beBeeMedicalDevices Full time

    Regulatory Specialist for Medical DevicesWe are seeking a highly skilled Regulatory Specialist to join our team in supporting medical device projects.The ideal candidate will have strong knowledge of regulatory requirements and guidelines, as well as excellent writing and communication skills.Create, update, and manage regulatory documents including Clinical...