Role Overview

We are looking for candidates with strong hands-on experience in Medical Device Regulatory Affairs who are interested in transitioning into a Solutioning role. The position involves understanding medical device regulatory services and supporting proposal development, client requirements, and solution-related activities.

Key Responsibilities

- Understand medical device regulatory and quality service requirements and translate them into structured solution inputs.
- Support the preparation of proposals, RFPs, RFIs, RFQs, SOWs, and other client-facing documents.
- Coordinate with internal teams, SMEs, Delivery, Sales, and other stakeholders to gather technical inputs and service-related information.
- Assist in developing capability presentations, service descriptions, case studies, and supporting documentation.
- Support pricing worksheets, effort estimations, trackers, and proposal-related documentation using MS Excel and PowerPoint.
- Ensure accuracy, completeness, and timely delivery of assigned documents and activities.

Required Skills & Experience





- 24 years of experience in Medical Device Regulatory Affairs and/or Medical Device Quality.
- Strong understanding of medical device regulatory requirements, including FDA 510(k), EU MDR, ISO 13485, CDSCO, regulatory submissions, product registrations, PMS, vigilance, labeling/UDI, or market access.
- Good understanding of medical device regulatory processes and compliance requirements.
- Strong communication, analytical, documentation, and stakeholder management skills.
- Working knowledge of MS Excel and PowerPoint.
- Interest and willingness to transition into Solutioning, proposal development, and client-focused activities.

Qualifications Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Sciences, Engineering, or a related discipline.

Important Note

Prior experience in Solutioning, Presales, Proposal Development, RFP/RFI/RFQ management, or commercial documentation is NOT MANDATORY. Candidates with solid Medical Device Regulatory Affairs experience who are interested in exploring and transitioning into Solutioning are encouraged to apply.

📌 Medical Devices Regulatory Solutioning Associate (Hyderabad)
🏢 Freyr
📍 Hyderabad