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



  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • Perungudi, Chennai, Tamil Nadu, India MORULAA HEALTH TECH PVT LTD Full time

    Job Summary The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable regulations governing the development, manufacturing, and distribution of the company's products. This role involves collaborating with internal teams and regulatory agencies to facilitate product registrations, approvals, and adherence to quality...

  • Regulatory Affairs

    2 weeks ago


    Bengaluru / Bangalore, Chennai, India Ajay Bhardwaj (Proprietor Of Ocean Biomed) Full time

    Summary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...


  • Chennai, Tamil Nadu, India ClinChoice Full time

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for an Executive - Regulatory Affairs (PLMDS) to join one of our clients. **Main Job Tasks and Responsibilities**: - Complete...


  • Chennai, Tamil Nadu, India Ovesco Endoscopy India Private Limited Full time

    Regulatory AffairsThis is us:Ovesco Endoscopy is a research-based medical device company specializing in flexible endoscopy.We develop, produce, and sell highly innovative instruments and systems for the treatment of gastrointestinal diseases. We offer comprehensive procedures and accompany our customers all the way from training to intervention.This is you:...


  • Chennai, India TTK Healthcare Full time

    Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature search,...


  • Chennai, India TTK Healthcare Full time

    Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature search,...


  • chennai, India TTK Healthcare Full time

    Reporting to: Assistant Manager – Regulatory Affairs Division: Ortho Implants Location: Chennai No. of Positions: 1 Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs Experience: 2 - 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred KEY RESPONSIBILITIES: Technical writing, literature...


  • Sahibzada Ajit Singh Nagar, Ludhiana, Punjab, India UTS Global.Site Full time

    We are looking of a Regulatory Affairs Executive for a Manufacturing Company located in DeraBassi (Punjab) Currently opening is for Regulatory Affairs department. ISO 13485 will be preferable. Qualification: Diploma (Electronics / Electrical / Mechanical) Experience : 5 TO 7 years **Salary**: 40K To 45K Location: DeraBassi **Job Types**: Full-time,...


  • Chennai, India Guires Solutions Pvt Ltd Full time

    **Industry** Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications **Position** Full Time, Permanent **Division** Pubrica Brand **Reports to**: Pubrica Business Head **About Company** Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot...


  • Chennai, Tamil Nadu, India Healthcare (OHQ) Full time

    Job Title:Regulatory Affairs and SCM -ExecutiveLocation:Chennai, IndiaEmployment Type:PermanentAbout OMRON Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMORN has a strong presence in Industrial Automation, Healthcare, and Device & Module...


  • Balaji Nagar, Pune, Maharashtra, India Vertex Business Solutions Full time

    Regulatory Affairs Executive act as a link between companies and regulatory authorities, ensuring that products are manufactured, tested and distributed in compliance with appropriate legislation. **Responsibilities**: - studying scientific and legal documents to check they meet legal requirements. - Gathering, evaluating, organising, managing and...


  • CV Raman Nagar, Bengaluru, Karnataka, India Indian Institute of Science, Bangalore Full time

    **About Company**: Foundation of Science, Innovation and Development (FSID) and Department of Design and Manufacturing (DM) at Indian Institute of Science (IISc), Bengaluru support the research, development, and commercialization of affordable and accessible medical devices for indigenous and resource constrained populations. The research team from IISc is...


  • Chennai, India Healthcare (OHQ) Full time

    **Job Title**:Regulatory Affairs and SCM -Executive **Location**:Chennai, India**Employment Type**:Permanent**About OMRON** - Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMORN has a strong presence in Industrial Automation, Healthcare, and...


  • CV Raman Nagar, Bengaluru, Karnataka, India Indian Institute of Science, Bangalore Full time

    About Company:Foundation of Science, Innovation and Development (FSID) and Department of Design and Manufacturing (DM) at Indian Institute of Science (IISc), Bengaluru support the research, development, and commercialization of affordable and accessible medical devices for indigenous and resource constrained populations.The research team from IISc is...


  • Chennai, India INTERMED Full time

    Explain regulations, policies, or procedures - Maintain data in information systems or databases - Ensure compliance with regulations - Advise others on regulatory and compliance matters - Evaluate applicable laws and regulations to determine impact on company activities - Provide technical review of data or reports - Coordinate regulatory documentation...