Business Development Executive - Proposal Team

Seeking a skilled Proposal Writer to join our OEM medical device team. In this role, he/she will be responsible for developing, writing, and submitting clear and compelling proposals in response to RFPs, RFIs, and other business opportunities. He/she will collaborate with cross-functional teams including engineering, regulatory, and manufacturingto gather technical details and ensure compliance with industry standards and regulations (e.g., FDA, ISO 13485, MDR). The ideal candidate will have excellent writing skills, a strong understanding of the medical device industry, and the ability to manage multiple projects under tight deadlines.

Roles & Responsibility

Proposal Development and Writing: Research and write clear, concise, and compelling proposals for new business opportunities, including bids, RFPs (Request for Proposals), RFIs (Request for Information), and grants within the medical device sector.

Collaborate with cross-functional teams (engineering, regulatory, quality assurance, manufacturing, and sales) to gather technical information, pricing details, and other necessary content.

Market and Competitive Analysis: Conduct research on prospective clients, competitors, and market trends in the medical device industry.

Compliance and Regulatory Documentation: Work closely with regulatory and legal teams to ensure that proposals meet all necessary industry regulations and standards, such as ISO 13485, FDA 21 CFR Part 820, and MDR/IVDR (Medical Device Regulation/In Vitro Diagnostic Regulation). Address safety, quality assurance, and risk management aspects in proposals.

Project Management and Coordination: Manage timelines and ensure that all stakeholders contribute to the proposal content on time. Coordinate the proposal approval process with internal teams, ensuring alignment with the company's strategic goals and regulatory constraints. Prepare and revise drafts based on feedback from internal and external stakeholders.

Costing and Pricing: Collaborate with finance and supply chain teams to create accurate and competitive pricing strategies for proposed projects, including manufacturing costs, regulatory fees, and risk mitigation factors. Provide detailed cost breakdowns and justifications for clients as part of the proposal submission.

Client Communication and Presentations: Communicate directly with clients to clarify requirements, answer queries, and gather insights into their needs.

Prepare and deliver proposal presentations to clients, highlighting the companys strengths in manufacturing, product development, and regulatory compliance.

Technical and Product Knowledge: Maintain an in-depth understanding of the companys medical device products, manufacturing capabilities, and services offered.

Revision and Customization of Proposals: Review and revise proposal templates regularly to reflect changes in regulations, company offerings, or market needs.

Post-Proposal Follow-Up: Provide support during the post-proposal phase, assisting with negotiations, clarifications, and additional information as required by clients. Work with the sales and project management teams to track and respond to feedback on submitted proposals.

Documentation and Record Keeping: Maintain a well-organized library of past proposals, case studies, and technical documents for future reference. Ensure all proposal-related documentation is up-to-date and stored in compliance with company policies and industry standards.

Skills Required: -

1.Bachelors Degree (Required): A degree in a STEM field (Science, Technology, Engineering, Mathematics).

2.Beneficial Qualifications: Experience in the Medical Device Industry or related fields (healthcare, life sciences) is highly valued.

3.Certifications in regulatory affairs (e.g., RAC – Regulatory Affairs Certification).

4.Technical Knowledge in fields like biomedical engineering or healthcare technology could be beneficial, particularly in more technical writing roles.

5.Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, MDR/IVDR, or other medical device-related standards and certifications may be required or preferred.