Regulatory Affairs Specialist

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About Halma Company IZI:

Medical Halma Company IZI Medical is a leading innovator manufacturer and distributor of quality medical devices IZI Medical is a leading developer manufacturer and provider of high-quality medical consumable devices used in interventional radiology and oncology radiation therapy neuro-spine and image guided surgery procedures. IZI Medical :-

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:

• Bachelors degree in life sciences engineering regulatory affairs or related field.

Experience (exposure):

• Minimum 35 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.

If you like wild growth and working with happy enthusiastic over-achievers youll enjoy your career with us!

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