▷ (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 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...

  • 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....

  • 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**: -...

  • Back Office Executive

    3 weeks ago

    Ahmedabad, India Only Option Events Full time

    Company Description"Welcome to Only Option Events, your premier partner in event management, based right here in Ahmedabad. We specialize in collaborating with corporate entities to deliver flawless events that leave a lasting impression. From meticulously planning every detail to executing seamlessly on the day, our team ensures your event is a resounding...

  • Office Executive

    5 days ago

    Ahmedabad, India Only Option Events Full time

    Company Description ‘Welcome to Only Option Events, your premier partner in event management, based right here in Ahmedabad. We specialize in collaborating with corporate entities to deliver flawless events that leave a lasting impression. From meticulously planning every detail to executing seamlessly on the day, our team ensures your event is a...

  • 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...

  • Business Development

    1 month ago

    Ahmedabad, Gujarat, India Left Of Centre Marketing LLP Full time

    About the internship:Selected intern's day-to-day responsibilities include: 1. Conduct detailed research and prepare a database of potential clients/leads 2. Work on trying out different marketing strategies to pitch our services to them > Only those candidates can apply who: 1. are available for full time (in-office) internship 2. can start the...

  • Back Office Executive

    3 weeks ago

    ahmedabad, India Only Option Events Full time

    Company Description"Welcome to Only Option Events, your premier partner in event management, based right here in Ahmedabad. We specialize in collaborating with corporate entities to deliver flawless events that leave a lasting impression. From meticulously planning every detail to executing seamlessly on the day, our team ensures your event is a resounding...

  • Back Office Executive

    3 weeks ago

    Ahmedabad, India Only Option Events Full time

    Company Description"Welcome to Only Option Events, your premier partner in event management, based right here in Ahmedabad. We specialize in collaborating with corporate entities to deliver flawless events that leave a lasting impression. From meticulously planning every detail to executing seamlessly on the day, our team ensures your event is a resounding...

  • Back Office Executive

    3 weeks ago

    ahmedabad, India Only Option Events Full time

    Company Description "Welcome to Only Option Events, your premier partner in event management, based right here in Ahmedabad. We specialize in collaborating with corporate entities to deliver flawless events that leave a lasting impression. From meticulously planning every detail to executing seamlessly on the day, our team ensures your event is a resounding...

  • Back Office Executive

    3 weeks ago

    Ahmedabad, India Only Option Events Full time

    Company Description"Welcome to Only Option Events, your premier partner in event management, based right here in Ahmedabad. We specialize in collaborating with corporate entities to deliver flawless events that leave a lasting impression. From meticulously planning every detail to executing seamlessly on the day, our team ensures your event is a resounding...