Director of Regulatory Affairs and Clinical
We are seeking a Director of Regulatory Affairs and Clinical to provide independent regulatory/clinical guidance to product development teams on international pre-marketing applications.
The Role:
This role requires a high degree of flexibility, attention to detail, and good time management. The successful candidate will have relevant experience of bringing similar products to market.
Key Responsibilities:
* Preparation of submissions (CE and FDA IDE), including risk management reports, clinical risk evaluations.
* Regulatory submissions, statistical techniques, and FDA inspections expertise.
* Design Assurance support - Leading the day-to-day regulatory support for new products.
* Review of change control documentation for potential regulatory submissions.
* Vigilance and post-market related activities completion.
* Responsible for Regulatory Compliance (PRRC) as per Article 15 of MDR 2017/745.
* Identification and planning of regulatory and clinical activities, including continuous improvement initiatives.
* Representation of the company in collaborations with investigators, KOL's, CRO's and clinical hospital staff.
* Clinical publications: work closely with PI's and KOL's to define study protocols, select study sites, drive, and control execution, collect, and analyze data, support PI in writing up and publish study results.
* Ensure all activity meets business ethics responsibilities.
* Policies and procedures formulation, implementation, maintenance, and control to ensure full regulatory compliance.
* Medical device submissions preparation and review for market clearance and assessments.
* Strategy definition and direction of interactions with the US Food and Drug Administration (FDA) and international regulatory agencies.
* Product labelling, packaging, promotional materials creation and review.
* Support for the planning of product development and commercialization projects.
Requirements:
* Degree in Clinical, Regulatory or Science discipline.
* 5+ years' experience in Regulatory Affairs and/or Clinical Affairs roles desirable.
* Current understanding of FDA and ISO requirements.
* Strong Technical aptitude with an ability to analyze and challenge technical data.
* Experience in dealing with regulators and leading external agency inspections an advantage.
* Good interpersonal & communication skills essential.