Regulatory Affairs Officer

3 weeks ago

Gurgaon, India Manpower Group Full time

**Position : Associate Manager**

The primary role of this position is to support regulatory compliance, maintenance and continual improvement of the company with applicable regulatory requirements, business objectives, and customer needs.
- Ensure regulatory compliance with relevant global medical device regulations, including but not limited to FDA 21 CFR 820, EU MDR, Canada, UK requirements, and Switzerland regulations
- Creation, review and process of core regulatory, scientific and technical documentation dossier pertaining to In-vitro Diagnostic products & Medical Equipment.
- Manage the applicable sites FDA establishment registrations
- Maintain FDA listing for all medical devices in the FDA listing/registration system
- Lead design control documentation: design and development plan, design input, design verification, and other applicable regulatory documentation
- Lead CE mark technical dossiers, complete the required EU MRD documentation required to demonstrate compliance
- Review and approve NPIs (new product introductions) related to all medical devices
- Request and maintain the UDI requirements/barcodes for all devices in the GS1 system
- Maintain up to date UDI requirements in the FDA GUDUI database
- Review and approve labels for all our medical devices
- Review and approve as applicable change controls to assess regulatory impact
- Review and approve risk management documentation
- Review and approve Software related requirements related to FDA and IEC 62304 requirements
- Support as required FDA observations to ensure regulatory compliance.
- Support customer requests and questionnaires related to Regulatory items
- Review distributor/customers agreement related to Regulatory requirements
- Review and approve labelling and marketing materials for all our medical devices
- Develop relevant Regulatory best practice document/procedures as necessary
- Support distributor’s regulatory technical documentation for their submission
- Review distributor regulatory compliance status
- Responsible for the evaluation and submission of any global safety related reports to regulatory agencies
- Participate in QA management reviews
- Review applicable QA procedures to ensure RA global compliance
- Participate in INNOVA projects and lead Global product classification and registration requirements

Experience And Education Requirements:

- 5-8 years of experience within the regulatory function in a medical device company
- Experience with medical device design controls and global regulatory submissions (including but not limited to CE mark)
- Experience working within and complying with ISO 13485, and EU MDR

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

**Salary**: ₹400,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Gurugram, Gurugram - 122018, Haryana: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Master's (preferred)

**Experience**:

- total work: 6 years (required)

  • Regulatory Affairs Executive

    7 days ago

    Gurgaon, India career and job Full time

    REQUIRE REGULATORY AFFAIRS EXECUTIVE experience in medical devices **Job Types**: Full-time, Regular / Permanent **Salary**: ₹75,000.00 - ₹95,000.00 per month Schedule: - Day shift **Education**: - Bachelor's (preferred) **Experience**: - total work: 5 years (preferred) **Speak with the employer** +91 9136838735

  • Compliance & Regulatory Affairs Officer

    2 weeks ago

    Gurgaon, Haryana, India IndusInd Bank Full time

    About the role: We are looking for an experienced Compliance & Regulatory Affairs Officer who is well-versed in the current legal / regulatory frameworks applicable for Banks, Non Bank Financial Sectors, Insurance sector and corporate governance best practices in order to support all aspects of IndusInd's regulatory compliance practices including program...

  • Regulatory Affairs Associate 3+Yrs

    1 month ago

    gurgaon, India Rangam India Full time

    Job Description JOB DESCRIPTION Regulatory Affairs 3-4 years Experience Medical Devices & Drug products Summary: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of company’s...

  • Manager - Regulatory Affairs and Compliance

    1 month ago

    Gurgaon, India 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: About the Role: Reporting into the Asia RAQC Manager, you...

  • Manager - Regulatory Affairs and Compliance

    1 month ago

    gurgaon, India 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: About the Role: Reporting into the Asia RAQC Manager, you...

  • Manager - Regulatory Affairs and Compliance

    2 weeks ago

    Gurgaon, Haryana, India 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: About the Role: Reporting into the Asia RAQC Manager, you...

  • Manager - Regulatory Affairs and Compliance

    6 days ago

    gurgaon, India 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: About the Role: Reporting into the Asia RAQC Manager, you...

  • Manager - Regulatory Affairs and Compliance

    4 weeks ago

    Gurgaon, India 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: About the Role: Reporting into the Asia RAQC Manager, you...

  • Regulatory Affairs Associate 3+Yrs

    2 weeks ago

    Gurgaon, Haryana, India Rangam India Full time

    Job Description JOB DESCRIPTION Regulatory Affairs 3-4 years Experience Medical Devices & Drug products Summary: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of company's...

  • Compliance & Regulatory Affairs Officer

    2 weeks ago

    Gurgaon, Haryana, India IndusInd Bank Full time

    About the role:We are looking for an experienced Compliance & Regulatory Affairs Officer who is well-versed in the current legal / regulatory frameworks applicable for Banks, Non Bank Financial Sectors, Insurance sector and corporate governance best practices in order to support all aspects of Indus Ind's regulatory compliance practices including program...

  • Regulatory Affairs Manager

    2 weeks ago

    Gurgaon, Haryana, India Philips Full time

    JOB DESCRIPTION Job Title Regulatory Affairs Manager Job Description Job Description Business Title: Manager - Regulatory affaire In this role, you have the opportunity to make life better. Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So whatever your role, if you share our passion for...

  • Regulatory Affairs Manager

    2 weeks ago

    Gurgaon, Haryana, India Philips Full time

    Job TitleRegulatory Affairs ManagerJob DescriptionJob DescriptionBusiness Title: Manager - Regulatory affaireIn this role, you have the opportunity to make life better.Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you'll be working towards...

  • Regulatory Affairs Manager

    1 month ago

    Gurgaon, Haryana, India Philips Full time

    Job TitleRegulatory Affairs ManagerJob DescriptionJob DescriptionBusiness Title: Manager - Regulatory affaireIn this role, you have the opportunity to make life better.Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you'll be working towards...

  • Regulatory Affairs Manager

    4 weeks ago

    Gurgaon, Haryana, India Philips Full time

    Job TitleRegulatory Affairs ManagerJob DescriptionJob DescriptionBusiness Title: Manager - Regulatory affaireIn this role, you have the opportunity to make life better.Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you'll be working towards...

  • Regulatory Affairs Manager

    4 weeks ago

    Gurgaon, India Philips Full time

    Job TitleRegulatory Affairs ManagerJob DescriptionJob DescriptionBusiness Title: Manager - Regulatory affaireIn this role, you have the opportunity to make life better.Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be...

  • Regulatory Affairs Professional

    3 weeks ago

    Gurgaon, India Siemens Healthineers Full time

    **Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical...

  • Regulatory Affairs Professional

    3 weeks ago

    Gurgaon, India Siemens Mobility Full time

    Internal Title: Regulatory Affairs Professional External Title: Deputy General Manager Position Summary This position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's diagnostic imaging & therapy medical devices to be...

  • Executive, Regulatory Affairs

    4 weeks ago

    Gurgaon, Haryana, India Johnson & Johnson Full time

    Job title: Executive, Regulatory Affairs Overall purpose of job: Regulatory compliance for the Medical Devices marketed by Johnson & Johnson MedTech India To maintain the Life cycle management of the product registered by Johnson & Johnson Coordinate with internal stakeholders to Developed regulatory strategies and mitigate interdependencies of...

  • Executive, Regulatory Affairs

    2 months ago

    Gurgaon, Haryana, India Johnson & Johnson Full time

    Job title: Executive, Regulatory Affairs Overall purpose of job: • Regulatory compliance for the Medical Devices marketed by Johnson & Johnson MedTech India • To maintain the Life cycle management of the product registered by Johnson & Johnson • Coordinate with internal stakeholders to Developed regulatory strategies and mitigate...

  • Regulatory Affairs Professional

    2 weeks ago

    Gurgaon, Haryana, India Siemens Healthineers Full time

    Internal Title:Regulatory Affairs ProfessionalExternal Title:Deputy General ManagerPosition SummaryThis position is primarily responsible to ensure pre market & post market compliance to Medical Device Rules(MDR) 2017 governed by Central Drug Standard Control Organization (CDSCO) & state FDA for SHPL's IVD devices & medical devices to be sold in India.This...