We are seeking a Regulatory Affairs Specialist to join our rapidly growing international healthcare business based in Tullamore, Co Offaly. This is a great opportunity to be part of an organization that makes a real impact on millions of lives.
Key Responsibilities:
* Identify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant potential suppliers.
* Research alternative EU-based suppliers, improving our supply chain capability.
* Evaluate, and authorise if appropriate, changes to the manufacturing and supply chain processes.
* Approve product labels, package inserts and marketing material.
* Create and maintain audit-friendly product files for customers and HPRA assurance.
* A reliable and compliant supply chain is essential to the future of our expansion and our current business trading.
* Certification of ISO 27001 is a key element to our expansion and is strongly linked to our core value, customer service, and therefore is strongly linked to our future goals for the company.
The Person:
* A minimum of 3-5 years' experience in a medical device/healthcare industry in a regulatory position.
* Audit experience is essential.
* Excellent verbal and written communication skills.
* Excellent attention to detail skills.
* The person must be a self-starter in terms of time and task management, and be able to operate with minimal supervision.
* Possess strong Technical Writing ability.
* Have a methodical review approach, and be capable of initiating and leading change and continuous improvement.
* Ability to work within a team environment to achieve agreed company goals.
* Good understanding of ISO 27001, MDD v MDR & CE/UKCA.
Desired Skills & Experience:
* Manage CE mark Submissions, Significant Changes and Notified Body interactions.
* Manage the upcoming regulatory changes related to UKCA and MDR.
* Manage Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
* Work with the Commercial Team to ensure country-specific registration activities are understood and appropriately addressed.
* Lead Management Review process; report on the performance of the Quality System.
* Manage Design Control, Change Control, CAPA, Risk Management, Product Vigilance and Document Control Systems.
* Lead strategic quality improvement projects and initiatives which enhance the long-term sustainability of the company, including technology transfer and process improvement projects.
* Evaluate, and authorise, if appropriate, changes to the manufacturing and supply chain processes.
* Lead product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits, HPRA, WHO inspections, other regulatory inspections and supplier audits.
* ISO 27001 Management representative, manage all correspondence with Notified Body in order to achieve certification.
* Previous experience in dealing with public tendering processes would be desirable.
What you will receive in return:
* Competitive remuneration package.
* Opportunity to work with a company that works with innovative products that impact millions of lives.
* Healthy work-life balance, friendly work environment.