This vacancy is now closed

Regulatory Affairs Manager - Essex - Southern

Competitive Salary £££ - Medical/Pharmaceutical - Regulatory
Ref: 122 Date Posted: Monday 23 Apr 2018
LinkedIn ShareShare

based in Essex, an exciting opportunity has arisen for someone with a real eye for pinpoint precision. With the meticulous organisational skills that could rival Bill Gates or a modern-day Fibonacci, you will be playing an extremely important role in ensuring our clients have the appropriate licensing, marketing and legal compliance for their Medical and Industrial manufactured products.


The Role


As the Regulatory Affairs Manager, you will be based at our client’s southern seaside location and primarily responsible for running an extremely tight ship in terms of their continued compliance to all relevant regulatory and quality requirements. After the successful completion of your training, you will be the primary contact when it comes down to the identification and coordination of any regulatory changes to ensure there is no negative impact on the business as a whole, as well as keeping in line with current Health & Safety and Environmental procedures.


The Responsibilities


You will be liaising with the QA/RA (Quality Assurance/Regulatory Assurance) management team throughout the global organization making sure there is a consistent approach to regulation compliance across all facilities. Where applicable, you will notify all appropriate parties of any regulatory changes and review the impact these might have on the business to ensure that compliance is maintained and current standards and regulations are available.


You will have the task of generating and maintaining the DMR (Device Master Record), Declaration of Conformity and regularly attending and supporting Design review activities to compile an environmental checklist, labelling, IFU (Instructions For Use) and ER (Essential Requirements) checklists respectively. You will manage the ECR/ECO (Engineering Change Request/Engineering Change Order) making sure that all relevant S-BCs are notified of any changes which are required under regulations during the Change Management Process.


Any complaints that are received and any reportable events should be duly noted in a timely manner for review to determine and record reportability as per market regulations, as well as notifying Senior Management where appropriate. You will also determine whether FSCA (Field Safety Corrective Action) is required and generate any necessary Recall files whilst managing any activities during the Recall process to ensure it is up to date.


The Regulatory Affairs Manager will provide support during Product Registration as required and supply any information in line with FDA 510(k) and CE marking amongst other site/establishment registrations.  You will regularly participate in Continuous Improvement activities and assess the adequacy of Risk Management/Technical File/Standard Operating Procedures (SOPs), reviewing where appropriate.


Qualifications and Experience


  • University degree in a scientific/engineering subject. 
  • At least five years’ experience in a regulatory or quality role for a medical device manufacturer.
  • Ability to perform ISO 9001/13485 audits.
  • Good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.


Our client is a global Medical Device company with multiple facilities in the UK, across Europe, The USA and Asia. Producing world class products in terms of quality, cost and delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, they continue to invest in both their people and the latest equipment and processes to remain at the forefront in manufacturing technology.


The Next Step


Medical Engineers welcomes enquiries from all quality management backgrounds relating to science and engineering within medical technology and other highly regulated industries. Regardless of your current team size and structure, we will treat all communication in strict confidence.


Calls can be arranged outside office hours, please let us know in your communication and we will get this arrange in a time to suit you.


Contact: Jonathan Sleight

Direct: 0161 2600 193



Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

Contact Us Today