Senior Regulatory Affairs Officer

1 month 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

    2 months 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 Officer

    1 month ago

    Ahmedabad, Gujarat, India Swastik Placement Agency Full time

    **Position : Regulatory Affairs Officer/Executive (Female)** **Education : B Pharm (Preferably)** **Experience : 1-2 Years** **Work Profile**: 1. Preparation & Checking of Dossiers of formulation products for product registration in other countries. 2. Co-ordination with Manufacturer & our partner in country (With their regulatory person) 3. Travel may...

  • Regulatory Affairs Executive

    2 months 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

    1 month 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

    1 month ago

    Ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

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

  • Senior Regulatory Affairs Officer

    1 month ago

    Ahmedabad, India Aegis Lifesciences Pvt Ltd Full time

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

  • Regulatory Affairs Officer

    1 week ago

    Ahmedabad, India Rediant HR Management Full time

    Keep in touch with international legislation, guidelines and customer practices Keep up to the date with a company’s product range Ensure that a company’s products comply with the current regulations. Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a specified time frame in...

  • Regulatory Affairs Executive

    1 month 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 Officer

    1 month ago

    Sanand, Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Regulatory Affairs (Asia Pacif & Africa) (Female B.Pharm / M.Pharm Executive / Sr Executive 3-6 Years Sanand Ahemdabad Pay: From ₹12,000.00 per month Work Location: In person Application Deadline: 10/06/2024 Expected Start Date: 08/05/2024

  • Regulatory Affairs Trainee Officer

    1 month ago

    Ahmedabad, India CUBIT LIFESCIENCES LLP Full time

    Regulatory Affairs Department Must be M.Pharm Person Required Freshar can aply **Salary**: From ₹12,000.00 per month **Benefits**: - Provident Fund Schedule: - Day shift Supplemental pay types: - Yearly bonus Ability to commute/relocate: - Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work...

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

    4 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

    1 month ago

    Ahmedabad, India Bonetech Medisys Pvt Ltd Full time

    Qualification: Study in Regulatory Affairs ( With Good Communication Skills) Experience: 1 to 2 Year (Fresher can also apply) Vacancy : 2 Male \ Female **Salary**: From ₹12,000.00 per month Schedule: - Day shift Ability to commute/relocate: - Hathijan, Ahmedabad - 382445, Gujarat: Reliably commute or planning to relocate before starting work...

  • Regulatory Affairs Executive

    2 days ago

    Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full time

    Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience in similar profile or work area. **Job description**: - Preparing Dossiers for registration of products in various ROW markets and query response submission - Legalization of FDCA documents for respective country registration - Arrangement of Sample for registration submission...

  • Regulatory Affairs Executive

    1 month 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

    2 months 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

    1 month ago

    Ahmedabad, Gujarat, India Winston HR Services,Ahmedabad Full time

    POSITION :REGULATORY AFFAIRS EXPERIENCE : 0 TO 1 QUALIFICATION : B.PHARM, M.PHARM. JOB LOCATION : AHMEDABAD mo: 7383005000 SHIVANI WINSTON HR SERVICES **Salary**: ₹15,000.00 - ₹20,000.00 per month Schedule: - Day shift **Experience**: - total work: 1 year (preferred) Ability to Commute: - Ahmedabad, Gujarat (required) Ability to...

  • Regulatory Affairs Executive

    1 month 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. -...

  • International Regulatory Affairs Executive

    3 days ago

    Ahmedabad, India KARMAN AGENCY Full time

    Dear All, We are hiring International Regulatory Affair Executive/ Assistant Manager for one of the leading Pharmaceutical company in Ahmedabad. Experience: 3 - 8 Years Location: Thaltej, Ahmedabad Education: B. Pharma/ M. Pharma Pay: ₹15,000.00 - ₹60,000.00 per month Schedule: - Day shift **Speak with the employer** +91 9106816195

  • Executive Regulatory Affairs

    1 month ago

    Ahmedabad, India ADVANOV PHARMA PVT LTD Full time

    Review documents received from the manufacturing facilities - Compilation of documents as per guidelines of the respective country - Compilation of dossier as per country guideline - Follow up with the sites for documents, samples, and artworks - Resolving query raised by distributor or MOH - Dossier planning and tracking - Registration sample preparation -...

  • Regulatory Affairs Executive

    2 days ago

    Ahmedabad, Gujarat, India MNR Solutions Private Limited Full time

    **Job Summary**: The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR and Annual reports etc to Regulatory authorities. Queries response...