Website:
mycareernet.in
Job details:
Key Skills: Regulatory bodies, NPD, Manufacturing
Roles and Responsibilities:
- Prepare regulatory submissions and interacts cross-functionally to ensure OTD of product launches.
- Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required.
- Provided guidance on safety and regulatory matters throughout the design, manufacturing, and inspection processes, ensuring international market approvals.
- Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU.
- Implements continuous improvements and efficiencies using DBS tools.
Skills Required:
- Serves as RA lead on new product (NPD) core teams including medium to complicated instrument, software projects, systems and submissions (510(k), De Novo, Class 1, 2 & 3).
- Possesses a high level of technical understanding of hardware, software, wireless connectivity, and safety guidelines and regulations such and RoHS, REACH, and EMC testing requirements.
- Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions that are in scope for the initial product launch (US, EU, WHO/PQ).
- Authors and prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan.
It would be a plus if you also possess previous experience in:
- Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions.
- Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations.
- Experience with HW and SW testing including EMC and safety testing.
Education: Bachelor's degree in field with 8+ years of related work experience OR Master's degree in field with 6+ years of related work experience OR Doctoral degree in field with 3+ years of related work experience
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