Our client, a start-up based in Galway, is looking to hire a Director of Regulatory Affairs and Clinical as they continue to grow and expand operations.
The Role:
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 PIs in writing up and publishing 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 teams 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 and communication skills essential.