Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
Job Title: Regulatory Affairs Manager
Job Location: Nottingham UK
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
As a Regulatory Affairs Manager you’ll support the Global Head of Regulatory Affairs & Quality Assurance in staying ahead of legislative changes and ensuring compliance. You’ll be the goto person for keeping our technical files up to date and ensuring our medical device products meet global legislation. You’ll manage product labelling and artwork assess medical device complaints and handle customer complaints involving National Authorities. Your keen eye for detail will help us maintain our Quality Management System (ISO 13485 and ensure continuous improvement.
You’ll also be responsible for regulatory intelligence monitoring changes in medical device legislation and alerting stakeholders proactively. Your role will involve global product registrations and renewals reviewing legislation changes and maintaining our medical device legislation trackers. You’ll work closely with the Compliance Manager to update our approved suppliers list and make sure new suppliers meet our due diligence requirements.
Your expertise will be crucial in advising on legislative changes speaking with notified bodies and competent authorises conducting internal audits and managing product labelling and packaging requirements. You’ll also handle Health Hazard Evaluation Assessment maintain the artwork master list and oversee our new materials evaluation process.
To be the best in this role you’ll need previous global medical device and regulatory experience. Have a solid understanding and application of global medical device legislation and conformity processes for Class I medical devices. Additionally you’ll need ISO 13485 Quality Management systems and procedures experience.
https://lifelancer/jobs/view/9fa52341c1fd966ad0106ec6e92ca14d
Employment Type
Full Time
