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Regulatory Specialist in Belfast at Stryker Corporation

Date Posted: 2/28/2019

Job Snapshot

Job Description

Responsible for supporting a team of regulatory specialists in the interpretation of requirements and implementation of updates to ensure compliance to MDSAP, ISO 13485: 2016 and MDR for a class III medical device.

The RA Specialist will be responsible for the following activities:

Supporting interpretation of MDSAP and EU-MDR

Supporting the identification of actions required to ensure compliance with ISO 13485, MDSAP and MDR

Providing inputs to the project manager and Snr RA Specialist to support the creation of project plans for MDSAP and EU-MDR

Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with MDSAP and EU-MDR

Conducting updates to labelling, SOPs, work instructions and policy documents to ensure compliance with Stryker corporate SOPs

Supporting internal and external audits as required

Supporting regulatory submissions and registrations as required Managing the regulatory team on a day to day basis

Supporting creation of Quality Agreements as required

Work From Home: No

Travel Percentage: Up to 25%

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