Senior Regulatory Affairs Lead

Collins Mcnicholas Recruitment

Waterford

Role Responsibilities: Coordinate global regulatory impact assessment of manufacturing changes in collaboration with Regulatory Product Leads. Lead and drive post-approval regulatory strategies for marketed products with input from Regulatory Product Lead as needed. Provide input into regulatory strategy for development products. Author appropriate “Quality” sections of the technical documentation based on input from the Legal Manufacturer, Quality, Operations or Research & development. These sections include but not limited to manufacturing process description, analytical methods, specifications, stability. Review design related documents as appropriate and participate in the Risk Management Process. Prepare responses to deficiency letters or inquiries from Notified Bodies or Health Authorities regarding the “Quality” part of the technical documentation. Provide regulatory support to other functions during Regulatory Authority inspections. Serve as Regulatory Affairs representative on facility/site Local Change Management Boards. Participate in assigned due diligent business activities. Review and provide input on proposed health authority guidance documents. Role Requirements: Bachelor’s degree in science, engineering, pharmacy or other health related field. Advanced degree highly preferred (MS, Pharm.D, Ph.D. or equivalent. 8+ years medical devices/pharmaceutical industry and 6+ relevant regulatory CMC experience with at least 3+ years specific experience in supporting medical devices. Regulatory submission experience with Class I, II and III medical devices in US and Class IIa & IIb in EU and working knowledge of Technical Files. Knowledge of development and life-cycle management support of medical devices and/or combination products. Knowledge of current and emerging issues and trends of the medical device regulatory environment. Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business. Ability to influence external regulatory stakeholders and shape the external regulatory environment. Ability to interpret Regulatory Authority policies and medical device guidance and correctly apply them as appropriate in product development and post-approval activities. Ability to influence and partner with cross-functional teams. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data. Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. Excellent communication skills; both oral and written. Strong interpersonal skills with the ability to influence others in a positive and effective manner. Demonstrated ability to contribute to a continuous learning and process improvement environment. Capacity to react quickly and decisively in unexpected situations. For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie. 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.

1830 days ago