*Please note no sponsorship available, so those on graduate visa will not be suitable for this role as this role will progress into a senior role and likely to out run your visa.

1. Overall Purpose Undertake key technical and regulatory activities to support the continued FDA/CE/UKCA marking of company devices. Performs complaint investigations and conducts active maintenance of technical documentation across the full product lifecycle.

2. Key Tasks

• Undertake customer complaint investigations in accordance with 21 CFR 820.198 and ISO 13485.

• Participate in determining reportable events/incidents as per regulatory guidelines in UK, EUand US,. Conduct reporting activities to regulatory authorities via electronic reporting systems for FDA (eMDR), and MHRA (MORE) within stringent regulated timelines.

• Participate in the continuous application of risk management to ensure the intrinsic quality of company devices and contribute to the implementation and verification of inherent safety-by-design control measures.

• Update and maintain the risk management documentation to ensure compliance to ISO 14971.

• Maintenance of other technical documentation to ensure compliance to 21 CFR 820, ISO 13485 and MDR 2017/745 including:

o Design History File / Design and Development File.

o Device Master Record / Medical Device File.

o Technical Files.

• Participate in engineering change requests as part of the sustaining engineering required for marketed products. Maintain and update the corresponding technical documentation as appropriate.

• Evaluation of inspection non-conformities, perform necessary verification / validation, input into the determination of product disposition, and creation of concession rationales, as appropriate.

• Provide technical and regulatory input in the creation of regulatory filings. • Active participation in FDA site inspections and Notified Body audits for QMS, microbiology, and technical documentation.

• Provide technical support to other functions in the business including sales and marketing, QARA, loaner, and inspection.

• Conduct internal audits, utilising company audit program, questionnaire, and processes.

• Conduct external supplier audits, to ISO 13485:2016. This may require travelling abroad.

• Participate in the maintenance and creation of supplier and internal packaging and labelling specifications and documentation.

• Maintain and update documents associated with the maintenance, production and building of Loan and Consignment kits.

Knowledge, Skills, and Experience

• A degree in engineering, or a minimum of 2 years’ experience in a technical medical device role.

• Technical report writing.

• Ideally, a highly driven and proactive person who can work in a dynamic and fast paced team. Ability to work on multiple concurrent projects with parallel deadlines