Senior Regulatory Affairs Officer

3 weeks ago

Ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

Title/Designation:                   Senior Regulatory Executive

Based at:                                 Ahmedabad

Industry:                                 Medical Devices manufacturing (Class III)

Qualification:                          Postgraduate or equivalent in Pharma/Medical Devices domain 

Experience:                              5-6 years min.

Reports to:                              Head of QA/RA

About us:

Aegis Lifesciences, established in 2008, is a distinguished manufacturer and exporter of medical devices, headquartered in India. Renowned for its state-of-the-art facilities, Aegis specializes in the production of high-quality absorbable and non-absorbable haemostats, serving a diverse clientele across the globe.

·       Global Reach: Aegis caters to quality-conscious markets worldwide, including the EU, NHS-UK, CIS, Central America, Russia, LATAM, MENA, SA, and SEA

·       Remarkable Growth: With an impressive yearly growth rate exceeding 30%, Aegis has demonstrated substantial success in expanding its product portfolio and market presence

·       Quality Standards: Aegis upholds the highest quality standards, holding certifications such as ISO:13485, MDSAP, and CE (Class III medical devices). The company's facilities are registered with the United States Food and Drug Administration (FDA), reinforcing its commitment to quality and compliance

Aegis Lifesciences continues to drive innovation and excellence in the medical device industry, making significant contributions to global healthcare.

About the role:

We are seeking experienced candidates to join our dynamic team in the Quality Assurance / Regulatory affairs, in the field of class III / class D Medical devices Certification, QMS & Quality Assurance, Regulatory Compliances


As part of this role, you will be responsible for taking a leading role in the RA team and handle products registration and license renewal in various countries, compliance for international as well as local regulations for various class of medical devices. If you have proven expertise in this domain and like to take a leadership role in the QA/RA domain in the healthcare industry, we encourage you to apply and embark on a rewarding career journey with us.

 

Responsibilities:

 

The Senior RA Executive shall report to the Head of QA/RA, and is responsible to assist him in the following areas:

·       Leading new products registration and license renewal in various countries

·       Compliance for international as well as local regulations for various class of medical devices

·       To Lead QA/RA team and ensure quality SOPs within the company

·       Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment

·       Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes

·       Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects

·       Keep abreast of International legislation and guidelines of current product line in India

·       Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements

·       Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements

·       Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes

·       Review of SOPs, BPRs, specifications and change control to ensure compliance

·       Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks

·       Drives resolution of issues, communicates issues, impact and outcomes to the management team

·        Responsible for ensuring compliance to the submission standards, procedures and policies in India

·       Support Commercial Department in business development such as product evaluation and pre-launch activities

·       Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc

 

Candidate requirements:

 

●      Minimum 5 to 6 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry

●      Bachelors degree in relevant field. Master's is desirable

●      Ethical behavior and high level of integrity

●      Good teamwork, independent and committed to works across functional department

●      Possess good negotiation and dispute resolution skills

●      Demonstrated experience operating in a regulated environment

●      Ability to read, analyze and interpret governmental regulations & reports, scientific or clinical publications and data

●      Ability to write reports, business correspondence, and quality procedures

●      Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities

Address:

Factory: 215/216, Mahagujarat Industrial Estate,

Sarkhej-Bavla Road, At: Moraiya, Po: Changodar, Ta: Sanand


Marketing office: A-504 , Swati Trinity, Applewoods Township,

Near Shantipura Circle, Ahmedabad, Gujarat 380054

  • Regulatory Affairs Officer

    1 month ago

    Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full time

    Hiring for a **REGULATORY AFFAIRS OFFICER ** for our **Ahmedabad **location. Freshers with good knowledge should apply **Key Responsibilities**: - Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies. -...

  • Regulatory Affairs Executive

    1 month ago

    Ahmedabad, India Prime Placement Full time

    Position: Regulatory Affairs Assistant - Cosmetic Industry Department: Regulatory Affairs Experience Required: 0-2 years Location: Santej, Ahmedabad Salary Range: 2.2 LPA - 3 LPA Roles & Responsibilities: 1. Handling Legal Documents and Regulatory Affairs: - Assist in the preparation, review, and submission of regulatory documents. - Maintain and...

  • Senior Regulatory Affairs Officer

    3 weeks ago

    ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

    Title/Designation:                   Senior Regulatory ExecutiveBased at:                                 AhmedabadIndustry:                                 Medical Devices manufacturing (Class...

  • Senior Regulatory Affairs Officer

    3 weeks ago

    ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

    Title/Designation:                   Senior Regulatory Executive Based at:                                 Ahmedabad Industry:                                 Medical Devices manufacturing (Class III)...

  • Senior Regulatory Affairs Officer

    3 weeks ago

    Ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

    Title/Designation:                   Senior Regulatory ExecutiveBased at:                                 AhmedabadIndustry:                                 Medical Devices manufacturing (Class...

  • Regulatory Affairs Executive

    4 weeks ago

    Ahmedabad, India MJ SURGICAL Full time

    We are Hiring QA/Regulatory Affairs Specialist for Medical Devices (Orthopedic Implants and Instruments) **Role & Responsibilities**: 1. Documents preparation for ISO13485, CE Certificate (As per EU MDR). 2. Work on technical master file. 3. Work on CERs (clinical evaluation report) as per EU MDR. 4. Have knowledge about QMS (quality management systems). 5....

  • ▷ (Only 24h Left) Senior Regulatory Affairs Officer

    3 weeks ago

    Ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

    Title/Designation:Senior Regulatory Executive Based at:Ahmedabad Industry:Medical Devices manufacturing (Class III) Qualification:Postgraduate or equivalent in Pharma/Medical Devices domainExperience:5-6 years min. Reports to:Head of QA/RA About us: Aegis Lifesciences, established in 2008, is a distinguished manufacturer and exporter of medical devices,...

  • Regulatory Affairs Executive

    4 weeks ago

    Ahmedabad, Gujarat, India Angiplast Private Limited Full time

    “Job Description” **Position**:Regulatory Affairs - Executive Cum Microbiologist** **Department: Regulatory Affairs / Microbiologist** **Min Qualification: B.Pharm, M.pharm,Bio-Medical Engineer, B.Sc or M.sc with Microbiology** **Min Experience: 3 - 5 Years** **SAARY**: 30,000 To 60,000 **Industries Preferred: Medical Device / Pharma / Bio-Tech /...

  • Regulatory Affairs Executive

    1 month ago

    Vatva Gidc, Ahmedabad, Gujarat, India Fact Personnel Pvt Ltd Full time

    Position: Regulatory Affair Executive / Officer Location: Vatva, Ahmedabad Experience: 2- 7 years **Salary**: Hike on current CTC Skills: - Knowledge of Emerging Markets / Regulated Markets Worked on eCTD & CTD dossier OR Share with your friends! **Job Type**: Regular / Permanent **Salary**: ₹240,000.00 - ₹420,000.00 per year Schedule: - Day...

  • Regulatory Affairs Executive

    4 weeks ago

    Sarkhej, Ahmedabad, Gujarat, India Delwis Healthcare Pvt Ltd Full time

    **Job description** - Good communication skills client handling, Preparing/ checking and submitting technical files and compilation of dossiers in CTD/ACTD format as required for semi regulated countries/markets, - Product life-cycle management in ROW markets, - Handling product registration, - Providing regulatory support for out-licensing projects. -...

  • Regulatory Affairs Executive(Pharma Company)

    4 weeks ago

    Ahmedabad, Gujarat, India KK HR Services Full time

    Develops strategies to ensure the company’s production activities comply with government regulations. - Serves as a liaison between regulatory bodies and operating divisions of the company. - Responds to requests for information from regulatory bodies. - Coordinates with operations departments regarding production design and development to ensure...

  • Executive Regulatory Affairs

    4 weeks ago

    Ahmedabad, India Derrick Pharma solution Full time

    Experince: 2 Yrs to 3 yrs Qualification: Bpharm **Salary**: Depend on Interview. Designation: Regulatory Officer & Regulatory Excutive. **Salary**: ₹18,000.00 - ₹25,000.00 per year Schedule: - Day shift Ability to commute/relocate: - Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required) **Experience**: -...

  • Regulatory Affairs Executive

    4 days ago

    Ahmedabad, India Opes HealthcarePvt. Ltd. Full time

    Role Overview: - Responsible to prepare and review the dossier as per country specific guideline or CTD. - Responsible to submit error free dossier within timeline to reporting Manager - Responsible to prepare regulatory submission for international projects. - To resolve queries within timeline received from regulatory authorities. - To ensure company’s...

  • Regulatory Affairs Executive

    1 month ago

    Ahmedabad, India AG Digital Marketing Full time

    AG Digital Marketing is a marketing consultant that helps businesses grow their online presence through integrated digital marketing strategies. We combine SEO, PPC, and social media marketing to guide prospects through a unified online journey, enhancing brand impact and boosting leads and conversions. #agdigitalmarketing #agdigitalmarketinglife...

  • Regulatory Affairs Executive

    1 month ago

    ahmedabad, India Snaphunt Full time

    The Offer Opportunity to make a positive impact A role that offers a breadth of learning opportunities Work in a company with a solid track record of performance The Job Job Description: Dossier preparation as per the ACTD & CTD (Module I, II, III, IV, and V) guidelines. Technical documents like Raw Materials and finished products specification,...

  • Regulatory Affairs Executive

    1 month ago

    ahmedabad, India AG Digital Marketing Full time

    AG Digital Marketing is a marketing consultant that helps businesses grow their online presence through integrated digital marketing strategies. We combine SEO, PPC, and social media marketing to guide prospects through a unified online journey, enhancing brand impact and boosting leads and conversions. #agdigitalmarketing #agdigitalmarketinglife...

  • Regulatory Affairs Executive

    1 month ago

    Ahmedabad, India Snaphunt Full time

    The OfferOpportunity to make a positive impactA role that offers a breadth of learning opportunitiesWork in a company with a solid track record of performanceThe JobJob Description:Dossier preparation as per the ACTD & CTD (Module I, II, III, IV, and V) guidelines.Technical documents like Raw Materials and finished products specification, manufacturing...

  • Senior Legal Counsel

    7 days ago

    Ahmedabad, India Kraft Heinz Full time

    Position Title: Senior Legal Counsel, India Location: Ahmedabad, Gujarat Responsibilities: Guide and advise daily GCC activities to protect the company interest and ensure the activities are compliant with all the applicable laws and regulations, and to minimize business risks. Act as a trusted advisor to GCC management with respect to legal, regulatory...

  • Senior Legal Counsel

    1 month ago

    ahmedabad, India Kraft Heinz Full time

    Position Title: Senior Legal Counsel, IndiaLocation: Ahmedabad, GujaratResponsibilities:Guide and advise daily GCC activities to protect the company interest and ensure the activities are compliant with all the applicable laws and regulations, and to minimize business risks.Act as a trusted advisor to GCC management with respect to legal, regulatory and...

  • Regulatory Affairs

    4 weeks ago

    Ahmedabad, India Strava Healthcare Full time

    1. Preparation of dossiers, compilation of data 2. Aware of ACTD, CTD and coutry wise guidelines 3. Filing dossier to different countries for product registration 4. Query and responses