Job Opportunities at Maetrics

Individuals with a broad range and specialist areas in regards to medical device and IVD regulatory affairs, are in high demand especially with the implementation of MDR and IVDR. Positions can include strategic development with clients, hands on collation of technical files, remediation activities, consultancy and liaison with Notified Bodies/FDA, review of documentation, training and redevelopment of process areas such as Post Market Surveillance, Risk Management, Recalls and CAPA to name a few. Roles may cover pre-market and post market elements.

To be considered for a regulatory affairs position, you must have at least 3 years’ regulatory affairs experience, with senior roles requiring at least 8 years’ experience and Mangers at least 10 years’ experience. Director and above level require at least 15 years’ experience. Experience with at least either European or USA regulatory requirements is essential and experience with both is required for Manager and above positions. Experience of other country regulatory requirements is desirable but not essential. All regulatory affairs positions require the individual to have a good understanding of current regulatory challenges and be able to complete and submit a technical file for approval.

For a CAPA specialist position, candidates must have an excellent understanding of CAPA and routinely close CAPAs. Using root cause analysis techniques should come naturally and candidates should also be able to take the lead on ensuring CAPAs are adequately investigated, appropriate correction and corrective action is taken and effectiveness assessed.

Candidates must have excellent communication skills and the ability to deal with client at all levels in an organisation and the ability to provide examples of complex CAPAs they have had to deal with and also challenges they face on a regular basis. Knowledge and practical use of structured problem solving tools and techniques is required for CAPA roles.

A Complaint Specialist is responsible for evaluating and processing complaints received by a client. This can be to assist with a backlog of complaints, a remediation activity or following the implementation of a new complaints process or software. On occasion and for more experienced and seasoned individuals, a Complaints Specialist may provide consulting to clients on improvements and recommend changes to enhance their complaints procedures, plan and manage remediation activities, implement and train on new procedures.

A minimum of 2 years complaints experience is required and for senior and manager positions, 5 and 10 years’ experience is required respectively. Candidates who have managed complaint teams and implemented changes are highly desirable but also candidates who are at the beginning of their career and looking to progress are also of interest. All candidates require a full knowledge of compliant processes and regulatory requirements.

Delivering projects to clients at a high standard is very important to Maetrics. This requires a strong leader together with a capable and experience Project Manager. Our clients also require Project Managers to deliver on their internal projects. Project Managers may manage several project simultaneously or be dedicated to a long term intense client project with aggressive deadlines. Projects may range from a large scale remediation effort to managing a section of a larger project or a small but challenging project which carries additional responsibilities.

All project managers must have a minimum of 5 years of experience of practical project management and a minimum of 3 years experience in the life science industry. Strengths in one or all of Quality Assurance, Regulatory Affairs or Product Development is also required. A PMP or Prince 2 certification or similar is preferred.

Quality Assurance positions can include strategic quality development with clients, Quality consulting, gap assessments, design and development of quality systems, hands on remediation activities, consultancy and liaison with Notified Bodies/FDA, review of documentation, training and redevelopment of process areas such as CAPA, Document Control, Management Review, Internal Audits to name a few. Roles may cover pre and post certification requirements.

All roles require an understanding of either ISO 13485 or 21 CFR 820 with the more senior roles requiring a comprehensive understanding of both as a minimum. To be considered for a Quality Assurance position, you must have at least 3 years’ QA/QMS experience, with senior roles requiring at least 8 years’ experience and Mangers at least 10 years’ experience. Director and above level require at least 15 years’ experience. Experience of other country quality requirements is desirable but not essential. All Quality Assurance positions require the individual to have a knowledge of current quality challenges and be able to work at all different levels and area in quality.

The qualified individual will have completed multiple investigations and have Aseptic Manufacturing background. Must have pharmaceutical, medical device and/or combination device investigation experience.

Responsible for writing, reviewing and updating Clinical Evaluation Reports for clients’ product families, this position includes attending meetings with clients to gain an understanding of the product from the client product and technical leads and liaising with clients to gather information and data required to complete and update CERs.

Excellent verbal and written communication skills is a requirement for this position together with first-class written English and grammar. You must have a life science based degree with at least 5 years’ experience of medial writing, or a master’s degree with 3 years of medical writing experience or a PhD/Doctorate with at least 2 years of medical writing experience. All medical writing experience must be within the medical device industry. You will also need a minimum of 3 years’ experience of writing and reviewing CERs and 2 years’ experience of writing and reviewing CEPs.

As a qualified lead auditor, you would be responsible for planning, conducting and reporting results of audits for clients and their suppliers. Audits may be gap assessments, internal audits, vendor approval audits, vendor surveillance audits, pre assessment audits or mock regulatory audits. Auditors with audit experience in Medical Devices, IVDs, Pharmaceuticals and Biotech in either quality or regulatory requirements (including new requirements such as MDSAP, MDR, IVDR) are regularly required by the business.

Lead auditors must be a qualified lead auditor to GMP and/or ISO 13485:2016 standard and have excellent working knowledge of applicable regulations and standards such as 21 CFR 820, ISO 13485, MDD 93/42/EEC, Q10, GxP, ICH guidelines. Seasoned in auditing, lead auditors must have at least 5 years auditing experience of which 3 must be as lead auditor in both internal and external audits.

A strong background in the Medical Device, IVD and/or Pharmaceutical industry, and extensive experience working in a medical device, IVD and/or Pharmaceutical related industry.

Our Validation Engineers are required to write and review Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise. They own and develop validation master plans and documentation on behalf of clients and ensure all validation activities are carried out and reported in a timely manner, following the chronological order required by client standards. The role may include consulting and guidance on validation processes or hands on activities with the actual validation.

All validation engineers must have an excellent knowledge of Validation processes (IQ/OQ/PQ) and current regulatory requirements related to ISO13485/FDA CFR and/or GMP. Process Validation Engineers must have qualifications in lean manufacturing techniques.