Senior Regulatory Affairs Specialist

Description:

Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.

Our team powers Veryan’s business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.

Veryan’s culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.

Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs Specialist- Premarket will play a key role in supporting pre-market approval applications for Veryan’s products across international markets. This is a fantastic opportunity, which will allow the successful candidate to add real value to the future success of Veryan while working as part of a supportive, collaborative team in the new state-of-the-art facility in Galway. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities.

Job Requirements

Principal Responsibilities

• Compile international regulatory submissions for Veryan products under development, as required.
• Adhere to regulatory submission timelines, identify risks and appropriate mitigations.
• Review data intended for submission in international regulatory applications, identify gaps and make recommendations.
• Participate in risk management activities for designated projects.
• Provide regulatory input during the design control process of development projects at every design phase.
• Review and contribute to regulatory aspects of change control, labelling changes etc. during premarket development projects.
• Review and contribute to clinical evaluation reporting activities, and participate on clinical operations projects e.g. clinical investigation protocols.
• Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the MDR 2017/745, and FDA Quality System Regulations 21 CFR Part 820 and ISO 14971.
• Work with project management on project planning activities.
• Identify opportunities for improvement within the RA department.
• Support Regulatory team members with training as required.
• Support Veryan Quality System activities as required.

Education & Training

• A degree level qualification in Engineering, Science, QA, or related field is essential.