Executive Regulatory Documentation

2 days ago


Roorkee, India PYRAX POLYMARS Full time

**JOB DESCRIPTION ( Regulatory Documentation)**

**.* **Coordination with medical device consultant & will be responsible for creating documentation for certification & Compliance of (MDD)93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017*

**.* **Preparation of documentation for submission to INDIAN FDA*

**(CDSCO, NEW DELHI) for medical device mfg. certificate approval.**

**.* **FDA / CE / ISO 13485 - Screening of documents, compilation of dossier & drafting of letters and justifications.*

**.* **Internal-External audit compliances.*

**.* **Liasoning with drug department.*

**.* **Coordination with various consultants for preparation of regulatory documentation.*

**.* **Implementation of ISO 13485 & MDR in all Departments.*

**. Training of all departments regarding documentation & regulations.**

**Preference given**:
**. Good Communication, MS office**

**Qualification**

**.** Graduate/Post graduate

**Job Types**: Full-time, Permanent

Pay: ₹18,000.00 - ₹25,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

Work Location: In person



  • Roorkee, India Lucent Biotech Ltd. Full time

    **Full Job Description** **Job Profile: - Quality Control Executive (QC) Documentation** **Job Location: - Roorkee** **Qualification: - Bsc /Msc/ B.Pharm/ B.tech/Pharma** **Exp: - 2yr -3yr ( Pharma Division)(** (Tablet, Capsule, Liquids, Suspension, and Parental etc.). **JOB RESPONSIBILITIES** To strength and maintain the quality system in QC...


  • Roorkee, India Pyrax polymars Full time

    v **Preparation of documentation for submission to INDIAN FDA** v **(CDSCO, NEW DELHI) for medical device mfg. certificate approval.** v **FDA / CE / ISO 13485 - Screening of documents, compilation of dossier & drafting of letters and justifications.** v **Internal-External audit compliances** v **Coordination with various consultants for preparation of...

  • Executive

    5 days ago


    Roorkee, Uttarakhand, India MPL PHARMA Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for an Executive located in Paonta Sahib. The Executive will be responsible for overseeing day-to-day operations, coordinating with various departments, ensuring compliance with company policies, and driving strategic initiatives. The Executive will manage...


  • Roorkee, India Lucent Biotech Ltd. Full time

    **JOB RESPONSIBILITIES FOR PLANT DRA** **Experience**:2-5 years - Having experience in dossier preparation, compilation & review (CTD & ACTD) for CIS, ASEAN, LATAM, ROW & AFRICAN countries. - Collaboration with internal departments (Production, QA, QC and other concerned departments) to compile quality documents timely, as per country specific...


  • Roorkee, India Lucent Biotech Ltd. Full time

    Analysis of samples by chemical method and online reporting of in process and intermediate samples and analysis of in process validation samples. Analysis of samples by methods using HPLC,. Thorough knowledge on handling Validation & calibration of HPLC. Knowledge on handling of OOS, Deviations, Incidents. Should have Knowledge on Wet chemistry. Exposure to...


  • Roorkee, Uttarakhand, India Dev Staffing Solutions Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Company DescriptionJaidev Pharma Placement is a leading provider of human resources services in the pharmaceutical industry, offering positions and recruitment services across India. With over two decades of experience in Pharmaceutical Sales and Recruitment, we focus on providing top-notch human resources to clients at competitive rates.Role DescriptionThis...


  • Roorkee, India Elem consumer tech pvt ltd Full time

    The Supply Chain/Procurement - Executive will be responsible for overseeing and managing the company's end-to-end supply chain, logistics operations, and procurement activities. This role aims to enhance efficiency, reduce costs, and ensure reliable delivery of materials. **Responsibilities**: - Develop and implement procurement strategies. - Manage...

  • Ipqa

    2 days ago


    Roorkee, India PYRAX POLYMARS Full time

    1. Conduct in-process inspections (IPIs) to ensure compliance with GMP, SOPs, and regulatory requirements. 2. Monitor production processes, including manufacturing, packaging, and labeling. 3. Verify batch documentation, including batch records, labels, and packaging materials. 4. Perform line clearance, room clearance, and equipment clearance. 5....


  • Haridwar, Muzaffarnagar, Roorkee, India Desire Consultancy Service Full time US$ 90,000 - US$ 1,20,000 per year

    Min. 3+ yrs of relevant experience in export documentation.Strong working knowledge of DGFT norms, ICEGATE portal, FTA certificates, customs clearance procedures.(Familiar with INCOTERMS, international shipping procedures, and logistics coordination) Required Candidate profilePrepare, verify, and manage all shipping and export documents including Invoice,...


  • Roorkee, India Lucent Biotech Ltd. Full time

    **Full Job Description** **Job Profile: - Quality Control Executive (QC)** **Job Location: - Roorkee** **Qualification: - Bsc /Msc/ B.Pharm/ B.tech/Pharma** **Exp: - Fresher To 2yr ( Pharma Division)(** (Tablet, Capsule, Liquids, Suspension, and Parental etc.). **JOB RESPONSIBILITIES** - **Analysis of raw materials.** - **Analysis of working...