Regulatory Specialist
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| Job Type | Permanent |
| Area | Offaly, Ireland |
| Sector | Regulatory |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2828 |
| Job Views | 745 |
- Description
- Team Horizon is seeking a Regulatory Specialist for our client, who are a leading specialist provider of frontline medical and healthcare products.
Why you should apply:
This is an exciting oppoortunity to join an established yet growing company, with lots of scope for career progression.
What you will be doing:
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.
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
Approve product labels, package inserts and Marketing material.
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
Any other duties as assigned
What you need to apply:
Minimum of 3 years’ experience in a medical device/healthcare industry in a regulatory position.
Excellent verbal and written communication skills.
Excellent attention to detail skills.
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.
Analytical mindset and critical thinking
Excellent communication and people skills
Ability to quickly digest large amounts of data, perform analysis and identify trends to make business decisions based on data.
