Job title: Senior Regulatory Affairs Specialist – Premarket
Location: Parkmore, Galway. 1-2 days a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working


Company:
My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities.



Role:
As a Senior Regulatory Affairs Specialist you will will play a key role in supporting pre-market approval applications for their products across international markets. This is a fantastic opportunity, which will allow you to add real value to the future success of the company while working as part of a supportive, collaborative team in the new state-of-the-art facility in Galway. Work directly with R&D and Design Assurance throughout the full product lifecycle also work directly with regulatory authorities.



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.

• A degree level qualification in Engineering, Science, QA, or related field is essential.
• A minimum of five years experience at a senior regulatory level in the medical device industry is essential.
• A minimum of five years’ experience in the creation of regulatory submissions for premarket approval is required.
• Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
• Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.
• Excellent attention to detail and ability to produce reports at a high standard.
• Proven skills in the area of communication, organisation, computer literacy, problem solving and collaboration.
• Ability to work independently, with minimal supervision and use own initiative to respond to any issues arising.