We have a new opening for a Regulatory Affairs Specialist to join a well-established but rapidly growing international healthcare business based in Tullamore, Co Offaly. It is a great chance to be part of an organization that makes a real impact on millions of lives. The company have a significant presence in Ireland the UK and mainland Europe. This is a permanent position.
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 file for customers and HPRA assurance. A reliable & compliant supply chain is essential to the future of our expansion and our current business trading.
- A key element to our expansion will be the certification of ISO 27001. This 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.
For a confidential discussion and more information on this role, please contact
Gillian Nicholson
Direct: 090 6450665