List of Vacancies
Due to restructuring within our Technical Department we are currently recruiting for a Regulatory Affairs Manager and Laboratory Technician to join our expanding team.
Who are We?
Armstrong Medical create respiratory products which support healthcare professionals improve outcomes in critical care and operating departments. This focus has made us a global leader exporting to over 60 countries worldwide, and we have further ambitious growth plans.
All of our products are designed, manufactured and shipped from our 90,000-square foot facility in Coleraine on the picturesque Causeway Coast of Northern Ireland. People are at the core of our success and we encourage employees to realise their potential by offering outstanding training and support along with opportunities for career progression and personal development.
Where do you fit in?
Everyone in the business is encouraged to be creative, be supportive and to live life. We are proud of our culture and values which are at the heart of the Company.
We have high standards and we make no apology for it. After all, our products provide bespoke solutions for patients in acute respiratory care – from neonatal to end of life care. However, in return you will be rewarded with a wide range of benefits including:
· Ongoing training and support
· Positive working environment
· Incremental annual leave
· Onsite gym
· Childcare voucher scheme
· Discounted health cover scheme
Regulatory Affairs Manager – (salary £25k - £35k depending on experience)
To support the company in becoming the global preferred partner through assisting the Technical Director in meeting company goals and targets by providing a high level of administrative support and co-ordination and management of maintenance of regulatory approvals.
· Ensure there are adequate controls in place for the manufacture of own-brand labelled products and that OBL technical files are compliant.
· Maintain technical files in line with notified Body Requirements.
· Liaise during external and unannounced audits.
· Co-ordinate and oversee major regulatory clearance applications (e.g. US FDA 510(k) pre-market applications.
· Demonstrate continual improvement of the regulatory affairs function.
· Input to the requirements for documentation for national product registration activities.
Minimum 2 years’ relevant experience within a product regulatory control environment.
3rd level qualification in a related discipline.
In-depth knowledge of ISO 9001 or equivalent sector standard.
Closing date – 24th November 2017
Laboratory Technician – (salary £15k - £18k depending on experience)
To support the Company’s vision of becoming the global preferred partner supporting healthcare professionals to save lives in acute respiratory care by carrying out the testing requirements for manufactured product and product under development.
· Assist with Product Development / R&D projects as required.
· Be familiar with carbon dioxide absorbent production processes, to maintain up-to-date knowledge of how the product is manufactured.
· Review and update Operating procedures, QMS forms and Work Instructions.
· Assist in process production testing to verify the product is within specification and other associated inspections on the quality of product.
· Conduct internal audits as required.
· Maintain laboratory equipment, tidiness and cleanliness standard.
· Perform calibration of laboratory equipment as required.
Minimum 2 years’ experience of working in a laboratory environment.
3rd level qualification in Chemistry or other science related subject.
Closing date – 28th November 2017
Email your CV to firstname.lastname@example.org