Regulatory Affairs-eu ISO 13485: Usfda, Eumdr

3 days ago


Vasai, India Webbizzare Full time

Education: BSc/MSc/B-Pharm or a corresponding industry experience

Preferred Industry-Pharma Packaging / Medical Device/ Pharmaceutical

Major Duties & Responsibilities: Monitors regulatory affairs and the effect changes will have on company operations

Responsible for preparing and submitting regulatory documentation, including reviewing technical data and accuracy of filling.

Technical understanding of EU ISO13485:2016, 21CFR 820 EUMDR2017/745, PPE 2016/425, USFDA, MDR 2017 (As per CDSCO.

Responsible for assuring that all developed products/processes should represent the maximum quality & reliability attainable by establishing effective quality control inspections & corrective procedures.

Assessing technical documents as required standards (US& EU) Provide quality and regulatory affairs input for product development.

Handle all TQM & RA responsibilities through product development, design change, and post-market surveillance process.

Dossier preparation & submission and related activities to it & Post Submission support.

SOP preparation as per country guidelines for Dossier submission to be aligned with the requirement.

Keeping Track of Regulatory Requirements for changes and implementing them in the system.

Responsible for Process improvement for the Product approval process.

Maintain and continuously improve Quality System processes required by international and national regulatory authorities and standards.

Maintains current knowledge of regulations applicable to the company.

Required Skill Set: Extensive knowledge of EU & US government regulations.

Knowledge of pharmacopeia (EU, USP, JAPAN, INDIA) Excellent communication skills Problem-solving skills Good attention to detail Technical skills: EU ISO 13485:2016, USFDA, EUMDR, 21CFR etc.

Interested can call at 9821765157

**Salary**: Up to ₹1,000,000.00 per year

**Benefits**:

- Cell phone reimbursement
- Commuter assistance
- Flexible schedule
- Food provided
- Health insurance
- Internet reimbursement

Schedule:

- Day shift
- Evening shift
- Flexible shift
- Morning shift
- Night shift
- Rotational shift

Supplemental pay types:

- Commission pay
- Joining bonus
- Overtime pay
- Performance bonus
- Quarterly bonus
- Shift allowance
- Yearly bonus

Ability to commute/relocate:

- Vasai, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 4 years (required)

**Speak with the employer**
+91 9821765157



  • Vasai, India Lord's Mark Industries Pvt. Ltd. Full time

    Key duties of the job include: - studying scientific and legal documents - gathering, evaluating, organising, managing and collating information in a variety of formats - ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA) viz, CDSCO, FDA, WHO-GMP, CE certification. - maintaining familiarity with...


  • Vasai, India AVI Healthcare Pvt Ltd Full time

    **Qualifications** - Any Graduate, BE, B.Tech in Biomedical, BSc, BBM, BBA, Diploma **Role and Responsibility**: - Maintain company quality standards - Assist in maintaining the ISO 13485 System - Review products, processes and systems on an ongoing basis to determine where improvements can be made - Production support to ensure quality - Maintain complete...

  • Sorting Supervisor

    5 days ago


    Vasai, Maharashtra, India Ecolux Enterprises Full time

    Location Vasai Grade: Officer/ Sr. Officer Department: Production Reports To: Head of Department Work Experience: 3+ years of experience in a supervisory role within the medical device industry or a similar regulated manufacturing environment. Salary 2.00 - 4.00 LPA Education: Diploma or Bachelor’s degree in Engineering, Manufacturing, or a related...

  • Quality Technician

    2 weeks ago


    Vasai, Maharashtra, India AVI Healthcare Full time

    **Must be able to come for Interview in Andheri/Vasai** ***Joining**:Immediately **Location**: Vasai East **Qualifications** - Diploma in Medical Devices, Instrumentation, BSc Graduate, Biomedical Engineer or other related field. - Should be sincere, honest and hardworking and have analytical and problem-solving skills - Strong organizational and...


  • Vasai, Maharashtra, India SHIVA PRODUCTS Full time

    **Key Responsibilities**: - Support international sales activities, including processing purchase orders, preparing sales documentation (quotes, invoices, shipping documents), and coordinating shipments. - Serve as a communication bridge between overseas clients and internal departments (production, logistics, R&D, and finance). - Handle inquiries from...


  • Vasai, India Hire deluxe Full time

    **Job Description - Quality Control Coordinator / Assistant** This is a hands-on laboratory leadership position and job responsibilities for the position will include: v Leading process development for electroplating technologies, including definition and validation of preferred operating parameters, chemistry maintenance methods, and plating layer...

  • Qc Incharge

    1 week ago


    Vasai, Maharashtra, India Ceramat Private Limited Full time

    Quality Control Incharge Our Company is looking for Quality Control Incharge. **Company Description**: Ceramat Private Limited is a specialized manufacturer and supplier of nano hydroxyapatite and thermal spray grade hydroxyapatite. **Responsibilities**: - Knowledge / operation of XRD - Understand customer needs and requirements to develop effective...

  • Opening for QA/qc

    1 week ago


    Vasai, India Vivante Foods Pvt Ltd Full time

    Experience-5+yrs - Responsible for overall production (to monitor process control in core production areas like Cooking, Forming, Packing) and quality. Also ensuring Quality of raw materials, in process materials, Packaging Materials and Finished Products as per the organization specifications. - Coordinate with New/Existing Flavour companies for new...

  • R&d Executive

    7 days ago


    Vasai, Maharashtra, India Insight cosmetics Full time

    **Key Responsibilities**: - **Product Development**: Lead the formulation and development of new nail paint and hair care products, including shampoos, conditioners, treatments, and nail polishes. - **Research & Innovation**: Conduct thorough market research to identify trends in nail and hair care. Generate innovative product concepts based on consumer...

  • Plant Head

    1 week ago


    Mumbai, Vasai, Virar, India Umang Global Group Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Challenging opportunity to work as Plant-head of a large plant handling Pharma production.B.Pharma wit 10+ yrs exp in pharma plants ensuring the plant adheres to GMP&other international regulatory standards,such as those set by the FDA,WHO,ISO& MHRA.