Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Job description

Responsibilities

The Regulatory Affairs Consultant will be responsible for providing strategic guidance on regulatory requirements and submissions for medical devices.

This role involves ensuring compliance with global regulations, preparing and managing regulatory submissions, and acting as a liaison with regulatory agencies.

Key Responsibilities: Develop and implement regulatory strategies for medical device products throughout their lifecycle. Prepare, review, and submit regulatory submissions, including 510(k), PMA, CE Mark, and other international submissions.

Ensure compliance with applicable regulations, standards, and guidelines, including FDA, EMA, and other global health authorities.

Monitor and interpret regulatory requirements and changes, providing proactive advice to internal teams

Act as the primary point of contact with regulatory agencies, managing communications and negotiations to facilitate product approvals.

Conduct risk assessments and provide recommendations to mitigate regulatory risks.

Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure regulatory compliance.

Provide training and support to company staff on regulatory compliance matters.

Requirements

Strong knowledge of regulatory requirements and submission processes for medical devices.

Experience with regulatory submissions and interactions with health authorities.

Excellent communication and interpersonal skills.

Strong analytical and problem-solving abilities.

Ability to work independently and manage multiple projects simultaneously.

Proficiency in regulatory software and tools.

Required profile