Position Objective

(The purpose of role in current business/market scenario)

The Regulatory Affairs Specialist will support global regulatory activities for IZI Medical Products, with primary responsibility for preparing and maintaining EU MDR Technical Documentation and international regulatory submissions. The role will also support regulatory strategy, product lifecycle management, and global market expansion to ensure continued regulatory compliance throughout the product lifecycle.

Responsibilities (KRAs /deliverables / job expectations) • Prepare and maintain EU MDR Technical Files including GSPR, risk management, labelling, UDI, verification/validation evidence, PMS and clinical documentation. Maintain consistency across Technical Documentation, Design History File (DHF), Risk Management File, Design Verification & Validation, labelling, and manufacturing documentation. • Support international registrations and respond to Notified Body, Competent Authority, and regulatory agency questions. • Support preparation and maintenance of CERs including literature searches, clinical evidence evaluation, state-of-the-art reviews, and benefit-risk analysis. Perform regulatory impact assessments for clinical literature, standards updates, and regulatory guidance changes. • Prepare and maintain PMCF Plans, PMCF Evaluation Reports, PMS Reports, PSURs, complaint trends, and vigilance summaries. Monitor complaint trends, post-market surveillance data, vigilance activities, and published literature to support continuous clinical evaluation. • Ensure consistency between CER, PMCF, PSUR, risk files, IFUs, SSCP/SSCR (if applicable), and Technical Documentation, adhering to all applicable regulations and terminology. Participate in Technical Documentation gap assessments and remediation projects to maintain MDR compliance. • Support regulatory assessments for design, supplier, labelling, and product changes among all IZI product families. • Monitor changes to applicable regulations, harmonized standards, MDCG guidance documents, and international regulatory requirements; assess impact on existing products and recommend implementation actions. Work closely with Quality Assurance, R&D, Operations, Manufacturing, Supply Chain, Marketing, Clinical Affairs, and external suppliers to support regulatory compliance throughout the product lifecycle.

Critical Success factors

(critical / high impact aspects of role) • Hands-on experience compiling EU MDR CER, PMCF Plans/Reports, PMS Reports, and PSUR documentation. • Experience with clinical literature search strategies, appraisal, and documentation. • Experience supporting regulatory assessments for manufacturing, supplier, sterilization, and design changes. • Experience working with Notified Body questions regarding clinical evaluation, PMS/PMCF, PSUR, and Technical Files according to MDR regulations and guidelines.
• Experience with Class IIa/IIb sterile devices, implantable devices, biopsy needles, fiducial markers, or surgical/interventional devices preferred. • Experience with sterile medical devices, EO sterilization, packaging validation, and shelf-life validation preferred. • Strong regulatory writing and project management skills.

Academic qualification • Bachelor's degree in life sciences, engineering, regulatory affairs, or related field.

Experience (exposure) • Minimum 3-5 years of medical device regulatory affairs experience, including hands-on preparation of EU MDR Technical Documentation, CERs, PMS/PMCF documentation, and international regulatory submissions.

Key attributes (critical functional competencies)
• Analytical skills: Strong ability to collect and analyse data to identify patterns and potential liabilities is still often a part of the job description for many. • Interpersonal skills to effectively interact across functions working in a highly motivated team atmosphere. • Strong written and verbal communication skills and proven ability to present to internal and external stakeholders. • Strong and proven problem-solving skills. • Ability to independently manage multiple regulatory projects and competing priorities with minimal supervision. • Ability to travel to work with customers and suppliers. • Computer proficiency in Microsoft Office products (Excel, Outlook, PowerPoint, Word, Teams).

Competencies (fundamental skills and attitudes) • The ability to interact successfully across cultures. • Excellent English language communication skills, preferable with multiple languages. • Self-starter, able to work independently under tight deadlines. • Strong presentation skills and ability to conduct meetings. • You set high standards for yourself and others in the pursuit of excellence, honesty, integrity, and trust. • Be willing and able to operate in a lean environment and be creative and prudent in optimizing workflow. • Highly collaborative team player with the ability to engage quickly and help leadership Demonstrated ability to work effectively with global teams across multiple time zones.

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