Cache of job #14043431

Job Title

Regulatory Affairs Team Lead

Employer

Collins Mcnicholas Recruitment

Location

Westmeath

Description

The Regulatory Affairs Team Lead will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The regulatory affairs team lead position will assist in mentoring and development of staff members as part of the role. Regulatory Affairs Team Lead Responsibilities: Apply technical solutions to problem-solving. Provide leadership to the EMEA regulatory team. Working with Quality, Operations, Engineering and other internal groups investigate and recommend solutions to address potential regulatory issues. Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure. Provide regulatory support for global initiatives. Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks. Review and assess change control activities for potential impact on current regulatory filings. Maintenance of Regulatory procedures to ensure continued compliance. Ensure continual Quality System compliance by adherence to established and evolving internal requirements. Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management, and product labeling as they relate to registration and commercialization of medical devices. Support Regulatory inspections at the site as directed. Liaise with other departments to ensure correct supporting data generated and provided in a timely manner. Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives. ESSENTIAL SKILLS / EXPERIENCE. Engineering/Science qualification with 4/5 years of working within R&D/QA/RA in a medical device environment. 4/5 years experience in R&D, QA/RA, Validations – essential. Excellent technical writing experience within a medical device environment - essential. Attention to detail and accuracy – essential. Fluent English, both written and oral - essential. Ability to work well under deadlines and pressure. Excellent analytical ability. The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management. This role will be based in Athlone with travel to international sites. It is a permanent role. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

Date Added

1714 days ago

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