Regulatory Affairs Officer

4 days ago

T Nagar Chennai Tamil Nadu, India Sishya Meditech Pvt Ltd Full time

General Accountability Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.

**Responsibilities**:
1. Write, analyze, and edit technical documents to support countryspecific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.

2. Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.

3. Assist in preparing response to regulatory authorities questions within assigned timelines.

4. Stay abreast of regulatory procedures and changes in regulatory climate.

5. Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.

6. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.

7. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

9. Other duties as assigned.

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

**Salary**: ₹10,975.07 - ₹37,494.84 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- T Nagar, Chennai, Tamil Nadu (required)

Ability to Relocate:

- T Nagar, Chennai, Tamil Nadu: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**

+91 9840852256

  • Regulatory Affairs Officer

    6 days ago

    Egmore, Chennai, Tamil Nadu, India International Ingredients & Excipients Pvt Ltd Full time

    **Job highlights** - Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science. Qualification: M Sc Life Science/ BTech Medical / B Pharm/ M Pharm. - Minimum of 2-3 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation **Job description** This is a...

  • Regulatory Affairs Executive

    2 weeks ago

    Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

  • Regulatory Affairs Executive

    1 week ago

    Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

  • Regulatory Affairs Executive

    6 days ago

    Ambattur, Chennai, Tamil Nadu, India Gesco Healthcare Pvt Ltd Full time

    Company Description GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective...

  • Regulatory Affairs Executive

    1 week ago

    Chennai, Tamil Nadu, India MNR Solutions Private Limited Full time

    **Hi ,** **Urgent opening for Regulatory affairs -Executive** **Hiring **:Regulatory affairs -Executive **Location: - Chennai / Dehradun** **Experience: - 5+Years** **Notice Period: - 0-15 Days** **Industry : Pharma** **Qualification : M Pharma / B Pharma** ( **Knowledge of ROW, Emerging market, ZAZIBONA and EU market requirements and ICH guidelines...

  • Regulatory Affairs Executive

    1 week ago

    Tambaram, Chennai, Tamil Nadu, India Regenix Biosciences Ltd Full time

    Experience: 0 to 1 years of experience in Regulatory affairs. Qualification: B. Pharm / M. Pharm / MSc. Biotechnology Description: Regulatory Affairs Handling Dossiers License Queries CFT Communication Life cycle etc. *Immediate Joiners* Excellent in Communication Application Question(s): - Current CTC - Expected CTC - Notice...

  • Regulatory Affairs Executive

    1 week ago

    Tambaram, Chennai, Tamil Nadu, India Regenix Biosciences Ltd Full time

    **Experience**: 1 to 2 years of experience in Regulatory affairs. **Qualification**: B. Pharm / M. Pharm / MSc. Biotechnology **Description**: - Regulatory Affairs - Handling Dossiers - License - Queries - CFT Communication - Life cycle etc. **Immediate Joiners** Excellent in Communication **Job Types**: Full-time, Permanent Pay: Up to ₹28,000.00...

  • Regulatory Affairs Executive

    1 week ago

    Guindy, Chennai, Tamil Nadu, India Tekna Manufacturing Full time

    We are in the process of hiring Regulatory Affairs **Job Title**: Regulatory Affairs Executive **Key Responsibilities**: **Qualifications**: Bachelor Degree in a related field such as Biomedical engineering, Mechanical engineering with minimum of 2 years’ progressive Regulatory affairs experience in medical device & quality...

  • Regulatory Affairs Executive

    5 days ago

    Chennai, India Medopharm Full time

    Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review...

  • Regulatory Affairs Executive

    2 weeks ago

    Karapakkam, Chennai, Tamil Nadu, India CellBios Healthcare & Lifesciences Pvt. Ltd Full time

    **Key Responsibilities**: - **Regulatory Compliance**: Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices. - **Submissions and Approvals**: Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA,...