Director, Quality & Regulatory - Europe
Director, Quality and Regulatory - Europe
Reports to: Director, Quality – US Location: Dublin, Ireland
The Director, Quality and Regulatory Affairs Europe will be responsible for providing quality and regulatory support for the Europe Region as required under the EU MDR Regulations, and other European regulatory authorities. The individual will work closely with and under the direction of the Director of Quality with a dotted line to the VP Regulatory Affairs. Responsibilities include quality management of the global supply chain (including any third-party distributors), being the Company point of contact for the European Regulatory Authorities (PRRC), ensuring necessary regional regulatory policies and procedures are in place and developing regional regulatory strategies for pipeline projects, and having the overall responsibility for maintenance of European product registrations. This position involves both high-level strategic planning as well as hands-on responsibilities to support the growing pipeline and marketed product portfolio.
- Collaborate with development team to establish requirements
- Develop software to satisfy system and software requirements
- Produce documentation to satisfy IEC Medical Standards and FDA Guidance
- Responsible for Quality Management of the Global Supply Chain, which includes quality control of third-party distributors. Role will involve establishing the function to efficiently manage the quality onboarding and auditing of the global supply chain, including putting in place the required quality agreements.
- Person Responsible for Regulatory Compliance (EU PRRC) at Beyond Air Ireland Limited.
- Ensure continual Quality System compliance to site QMS, ISO 13485, and MDR.
- Responsible for Notified body (BSI) audits: MDSAP, MDR (Canada, EU, etc.), 13486:2016 outside the US.
- Responsible for regulatory submissions to new European markets for Beyond Air Ireland Limited in collaboration with VP Regulatory.
- Responsible for Vigilance system and Reportability of Adverse Incidents in all markets (Incl.- FSCA, FSN, Complaints, CAPA, Reportability Assessment) in the EU.
- Responsible for post-market surveillance activities outside the US and creation of corresponding documents (PMS Plan, PMS Clinical Follow-up Plan).
- Respond to queries from 3rd party suppliers and distributors related to product performance and quality.
- Part of Global Quality & Regulatory Affairs Team of Beyond Air Inc.
- Lead Product Support member of projects to ensure documented continued device compliance to applicable market regulatory requirements.
- Review and approve product labeling materials for compliance with applicable regulations and standards.
- Participate in internal/external company regulatory/quality audits.
- Managing preparations for audits in the EU-by-EU authorities.
- Lead RA representative for site change management with input into RA metric reporting.
- Maintain currency and accuracy of CE Technical Files aligned with device and process changes. Monitor global market regulatory changes, advise and/ or implement changes (with management approval) to ensure compliance.
- Keeping up to date with local and international legislation and guidelines
- Interpret new Medical Device Regulations and ensure compliance to internal procedures for continuous compliance with all regulatory requirements.
- Maintain up-to-date working knowledge of laws, regulations, and guidelines across the European regulatory authorities
- Prepare regulatory dossiers for submission to Health Authorities and Notified Bodies and for other International Regulatory agencies
- Work closely with US Regulatory Operations on electronic submissions and provide input on format and content of European regulatory submissions
- Creation and management of STED (Summary Technical Document– global standard) Technical Files for all range of devices outside the US, in collaboration with VP Regulatory.
- Leading device approvals in new and established markets in the EU for current and next generation products.
- Input to R&D activities, providing technical and regulatory support to R&D engineers.
- Supporting Marketing, Supply chain logistics and Sales team from a technical and regulatory standpoint.
- Clinical Evaluation Plan and Reports: Creation of Clinical Evaluation Plan and identifying and appraising clinical studies and summarizing information in a Clinical Evaluation Study Report
- Implementation of global regulatory strategy, interaction with multiple departments (Global Regulatory, Quality, Production, Commercial), project teams and regulatory agencies, and focusing on the data that supports the clinical efficacy and safety of products.
- Identifying issues and devising solutions, as well as exploiting potential and taking or directing whatever actions are required to maximize effective output.
- Act as the main Company contact with the European Regulatory Authorities.
- In close collaboration with the GRLs assist in the preparation of meeting requests and briefing documents for European Regulatory Authorities.
- Participate in team preparations for meetings with European Regulatory Authorities.
- In close coordination with GRLs, coordinate and prepare responses to requests for information from European regulatory authorities.
- Work with the appropriate partners within Beyond Air to establish, update, and implement European regulatory policies, standards, and procedures for the Company.
- Bachelor’s degree in a scientific or regulatory discipline (Masters Preferred)
- Minimum 7-10 years of experience in European Regulatory for drugs and/or medical devices
- Strong knowledge of EU MDR and experience working directly with European Regulatory Authorities.
- Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight; track record of successful Technical File submissions is desired.
- Must be highly proficient in use and knowledge of the English language, grammar and punctuation with strong written communication skills in the form of technical writing abilities and/or editorial experience.
- Integrity, ownership mentality, and a commitment to excellence.
- Excellent organizational skills and ability to work on multiple projects with tight timelines.
- Strong interpersonal skills and desire to work with project teams.
- Work outside the normal office hours as required
Please fill out the form below to submit your application.