- Represent Regulatory Affairs for EU sites on product life cycle development teams to ensure that all regulatory requirements are met throughout the development process.
- Updates and maintains all Design History Files and associated documents.
- Completes submissions to EU and FDA regulatory entities as needed.
- Creates and maintains product EU Technical Files
- Collects and coordinates information and preparation of regulatory documentation for submissions to regulatory agencies and advise on the submission strategy.
- Maintains regulatory files/database and chronologies in order
- Establishes and maintains a tracking system for changes in documents submitted to agencies and/or customers.
- Supports the sites in the timely renewal of certificates, licenses, and registrations
- Audits and ensures standardisation of all Product Technical Files.
- Assist in creation and approval of product labelling, TDS, MSDS, and instructions for use (IFU)
- Review and provide regulatory oversight for marketing literature for compliance with relevant regulatory requirements
- Provide the regulatory review of customer complaints and define their regulatory report ability as needed in post market surveillance activities
- By utilising regulatory knowledge and expertise, provide support and expansion of the Regulatory Services function as part of the Product Life Cycle Management (PLM) process to customers
- Maintain current knowledge of MDD, MDR, FDA and international regulations with guidance and standards applicable to company products
- Participate in research of regulatory issues and dissemination of regulatory information to Production, QA, QC, R&D department, and Senior Quality Management
- Execute compliance GAP audits with remediation plans at EU sites
- Support the acquisition of monthly regulatory quality metrics and KPIs.
- Monitor CAPA activities for key accounts internally and externally. Escalate process failures to Senior Management.
- Perform other activities as required.
- Knowledge of Quality systems and manufacturing processes
- Demonstrated experience interfacing with FDA/Regulatory inspectors and customers during customer audits
- Strong Project Management, technical, analytical & problem solving skills.
- Ability to respond to customers in a timely manner
- Excellent verbal, presentation, and written communication skills.
- Excellent interpersonal/communication/influencing/negotiation skills
- Ability to solicit feedback and information from others in an open environment.
- Ability to communicate effectively at all levels of the organisation and influence accordingly
- Strong regulatory affairs working knowledge and experience with quality systems regulations and guidelines, ISO 13485, ISO 14971, GMP (21 CFR 820), Medical Device Directive (MDD), Medical Device Regulation (MDR and US FDA regulatory requirements.
- A minimum of 5 years relevant experience within the regulatory affairs discipline, including Medical Device, Biotechnology, and/or Pharmaceutical experience.
- Experience with Class II devices mandatory, Class III desirable
- Sound analysis, ability to prioritise acts and effectively direct others with a thorough understanding of Quality Management requirements & processes.
- Represents Regulatory Affairs on product life cycle management project teams to ensure all regulatory requirements are met throughout the development process
- Enforce a culture of compliance and performance to the quality management system and regulatory requirements.
- Complete submissions to FDA and EU regulatory entities as required
- Provide regulatory knowledge expertise to ensure compliance to all regulatory requirements and laws