Greetings from Wellnest!
We have an excellent opportunity in the QA & RA Associate. Please find below the details regarding the same.
Name of the Company: Wellnest Health Monitoring Pvt. Ltd.
URL: https://www.wellnest.tech/
Wellnest is a med-tech organization that develops innovative, IoMT, self-care healthcare solutions. In a world that celebrates exclusivity, Wellnest aims to make healthcare inclusive. Wellnest is built on two defining values:
Healthcare must be more preventive & less reactive
Medical care must be a right and not a privilege
Wellnest is looking for someone to lead its QA, regulatory(RA), and compliance activities, including acquiring relevant manufacturing licenses, ISO certifications, CE, USFDA and more. The ideal candidate will be responsible for assuring compliance with applicable medical device regulations per jurisdiction, guidance and standards. They will be responsible for research, creation and maintenance of regulatory files, regulatory submissions, annual reports, registrations and listings.
QA&RA Associate:
Experience: 2 to 4 yrs
Job Location: Ahmedabad
Notice period: 30 days Max (Immediate Joiner will be given preference)
Job Responsibility:
- Research, write, analyze, and edit technical documents to support country specific 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.
- Help set up the correct manufacturing processes and suggest changes in manufacturing model whenever applicable.
- Assist in preparing responses to regulatory authorities questions within assigned timelines.
- Stay abreast of regulatory procedures and changes in regulatory climate.
- Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in a timely manner. Handle recalls and field actions, if required.
- Review and create product labels and review promotional material for compliance with applicable regulations and technical standards
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance
- Other duties as assigned.
Job Requirements/Skills:
- Must have the knowledge and experience with manufacturing licensing, CDSCO, ISO standards
- Should be able to single-handedly setup and lead the entire regulatory process for a startup (research to documentation to audits)
- Experience with successfully getting EU-CE and USFDA approvals for medical device is a huge plus
- Someone who has worked with setting up a regulatory team for medical device organization will get priority
If interested please share your updated resume along with below details on [Confidential Information]Total Exp:
- Rel. Exp:
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- Open for relocation to Ahmedabad (Gujarat) :
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