Our client, a start-up based here in Galway, is looking to hire a Director of Regulatory Affairs and Clinical as they continue to grow and expand operations.
The Role: As the Director of Regulatory Affairs and Clinical, you will provide independent regulatory/clinical guidance to product development teams on international pre-marketing applications and any related submissions to support optimal timelines for new/modified product launches. This role requires a high degree of flexibility, attention to detail, and good time management.
Responsibilities: Submission preparation (CE and FDA IDE), including risk management reports and clinical risk evaluations.Experience in regulatory submissions, statistical techniques, and FDA inspections.Support Design Assurance – Leading the day-to-day regulatory support for a new product.Review of change control documentation for potential regulatory submissions.Complete all vigilance and post-market related activities.Responsible for Regulatory Compliance (PRRC) as per Article 15 of MDR 2017/745.Identifies and plans regulatory and clinical activities including continuous improvement initiatives that support the Medical Device(s).Effectively represents the company in collaborations with investigators, KOLs, CROs, and clinical hospital staff.Drives and supports clinical publications: work closely with PIs and KOLs to define study protocols, select study sites, drive, and control execution, collect, and analyze data, support PI in writing up and publish study results.Responsible for ensuring all activity in this area meets business ethics responsibilities.Formulate, implement, maintain, and control RA/Clinical policies and procedures to ensure that full regulatory compliance with FDA, other Health authorities, and standard protocols is maintained or enhanced at all times.Lead the writing and review of medical device submissions to be made to the FDA or other Health Authorities for market clearance and assessments of proposed changes to existing products.Define the strategy and direct all interactions with the US Food and Drug Administration (FDA) and international regulatory agencies concerning submissions or filings to such regulatory agencies.Oversee and direct the processes for the creation and review of product labeling, packaging, promotional materials, etc.Support the planning of product development and commercialization projects. Organizes and prioritizes assignments for the RA/CA tasks.Read, review, interpret and keep current with local, regional, and national regulations and publications regarding medical devices.Interact with representatives of domestic and international partner companies and international regulatory authorities as needed to discuss regulatory issues and submission requirements.Work with regional/country commercial team and distributors to maintain country-specific registrations as needed.Requirements: Degree in Clinical, Regulatory, or Science discipline.5+ years' experience in Regulatory Affairs and/or Clinical Affairs roles desirable.The successful candidate will have relevant experience of bringing similar products to market.Current understanding of FDA and ISO requirements, with the ability to translate these requirements and implement them into the Quality system.Strong technical aptitude with an ability to analyze and challenge technical data, identify and address gaps, and generate technical reports to support submissions.Experience in dealing with regulators and leading external agency inspections is an advantage.Experience in making regulatory submissions valuable.Good interpersonal & communication skills essential.
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