Associate Manager - Regulatory Writing (Medtech)

TL;DR

Associate Manager - Regulatory Writing (Medtech): Leading complex medical writing projects and providing review support for clinical regulatory documentation with an accent on global filings and lean authoring principles. Focus on mentoring junior writers, managing cross-functional teams, and ensuring adherence to regulatory standards throughout the clinical development lifecycle.

Company

hirify.global is a technology-led healthcare solutions provider focused on enabling future-ready healthcare organizations through innovation and customer obsession.

What you will do

• Prepare and review clinical study reports, protocols, investigator brochures, and submission documents without senior guidance.
• Lead cross-functional teams to draft scientific content addressing data interpretation and product claims.
• Develop and maintain project plans, ensuring adherence to timelines and quality standards.
• Manage and mentor junior team members, facilitating their orientation and coaching.
• Coordinate document review meetings, consensus meetings, and quality control processes.
• Represent the Medical Writing department in cross-functional initiatives and stay current with regulatory landscapes.

Requirements

• Education: MBBS, PhD, MDS, BDS, MPharm, or PharmD.
• 10 to 12 years of experience in writing clinical and regulatory documents supporting global filings.
• Proven experience in authoring CSRs, protocols, ICFs, and CTD modules.
• At least 2 years of people management experience.
• Strong understanding of the clinical development process and regulatory guidelines.
• Effective communication, time management, and interpersonal skills.

Nice to have

• Strong knowledge of EU and US regulatory guidelines.
• Experience in building clinical or regulatory arguments in the absence of direct data.
• Expertise in MS Word functionality and document management systems.
• Ability to interpret complex scientific data for regulatory document writing.

Culture & Benefits

• Global fast-track career growth opportunities within a high-speed environment.
• Mentorship from industry experts in the intersection of healthcare and technology.
• Commitment to a culture of inclusion, diversity, and equal opportunity.
• Collaborative and purpose-driven work environment.