Position overview

Applies advanced regulatory expertise and professional judgment to develop and execute regulatory strategies that support the registration, lifecycle management, and commercialization of medical devices across assigned markets. Leads regulatory submission activities, assesses regulatory impact of product and manufacturing changes, provides strategic guidance to cross-functional stakeholders, and ensures compliance with applicable regulations while enabling business objectives.

Serves as a key regulatory representative on product lifecycle, sustaining engineering, manufacturing, supply chain, quality, and commercial initiatives, driving proactive regulatory solutions and effective engagement with health authorities.

Key Responsibilities

Regulatory Strategy and Compliance

• Develop and execute regulatory strategies for new product registrations, license renewals, product changes, manufacturing changes, and lifecycle management activities in assigned countries and regions.
• Interpret and apply applicable regulations, guidance documents, and standards to support regulatory decision-making and business objectives.
• Assess the regulatory impact of product, manufacturing, supplier, labeling, sterilization, process, and quality system changes and determine appropriate submission requirements.
• Provide regulatory guidance and recommendations to cross-functional teams during product development, sustaining engineering, and manufacturing initiatives.
• Monitor evolving regulatory requirements and communicate regulatory risks, opportunities, and implementation strategies to internal stakeholders.

Regulatory Submissions and Health Authority Interactions

• Prepare, compile, review, and submit high-quality regulatory submissions, including product registrations, amendments, notifications, renewals, technical dossier updates, and responses to health authority requests.
• Support submission planning activities, ensuring regulatory deliverables align with project timelines and business priorities.
• Develop scientifically and regulatorily sound justifications, rationales, and supporting documentation for submissions.
• Drive resolution of regulatory deficiencies, inquiries, and requests from health authorities.
• Serve as a primary regulatory contact with regulatory authorities, distributors, and external regulatory partners as appropriate.

Process Excellence and Compliance

• Ensure accurate maintenance of regulatory records and documentation within company systems.
• Support internal audits, external audits, inspections, and compliance assessments.
• Contribute to the development and maintenance of regulatory procedures, work instructions, and training materials.

Education and Experience

• Bachelor's Degree in Life Sciences, Pharmacy, Biomedical Engineering, Engineering, Biology, Chemistry, Regulatory Affairs, or related field.
• Minimum 3 years of experience in medical device regulatory affairs.
• Experience preparing and managing regulatory submissions for medical devices.

Additional Skills

• Excellent technical and regulatory writing skills.
• Strong analytical, critical thinking, and risk assessment capabilities.
• Ability to interpret complex regulations and translate them into practical business solutions.
• Strong project management and prioritization skills.
• Ability to manage multiple complex projects in a fast-paced global environment.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite and regulatory information management systems.
• Advanced English required