As a Regulatory Affairs Specialist, you will research, write, and compile technical documents for regulatory submissions in the USA, Canada, and Europe, while ensuring compliance with relevant guidelines. You'll assist in setting up manufacturing processes, handle regulatory authority inquiries, and manage device-related incidents.
2 to 5 years experience
Wellnest is looking for passionate individuals to join our team and help us achieve our goal of transforming the industry.
- 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
- 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 devices is a huge plus
- Someone who has worked with setting up a regulatory team for a medical device organization will get priority
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QA & RA Associate employer: Wellnest Health Monitoring Pvt. Ltd.
Wellnest Health Monitoring Pvt. Ltd. is dedicated to transforming the medical device industry by ensuring compliance with regulatory standards across the USA, Canada, and Europe. The company fosters a collaborative work environment where passionate individuals can contribute to innovative solutions in health monitoring. Employees have opportunities for professional growth through hands-on experience in regulatory affairs and quality assurance.
Contact Details:
Wellnest Health Monitoring Pvt. Ltd. Recruitment Team
