Principal ra - united kingdom, renfrew, renfrewshire

terumo aortic are looking for a principal ra to join our team during an exciting time of growth and expansion for the business. this is a fantastic opportunity for someone to join our regulatory affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.

the main responsibilities of the role are;

support ra representative during surveillance/ recertification audits (e.g. backroom, interviews etc as required)

lead and deliver regulatory projects (e.g. qms consolidation, udi, site investment, process improvements for ra and custom device ra processes as required)

perform, review and sign off of technical documents (rnd) for custom devices and ce devices including dtms, risk management files, design change evaluations, design reviews, capas, sats as required)

lead and coordinate activities for ra capas and sats from initiation to closure (including initiation, investigation, reports, implementing action plan as required)

represent ra and coordinate ra actions in business wide capas, sats and supplier change notifications as required

provide regulatory input to functional groups as required

perform technical documentation file reviews prior to submission for registrations

review of ra procedures for compliance

review and approve validation protocols and reports (e.g. site investment project)

facilitate in the compilation, communication and monitoring of fsn and recalls (if required)

other duties as required by ra department

review and sign off complaint reports

represent ra at change review board as required

the successful candidate will possess;

min 5ys regulatory and/or quality management experience within a medical device environment is essential

able to communicate with external parties: regulatory authorities, customers, distributors, notified bodies, competent authorities

able to communicate with personnel in qa/r&d and other departments

job types: full-time, permanent

additional pay:

bonus scheme

benefits:

additional leave

casual dress

company pension

cycle to work scheme

discounted or free food

life insurance

on-site parking

sick pay

work from home

schedule:

monday to friday

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