Medical Device Regulatory Compliance Manager
- Dublin, Ireland
Site Name: Ireland - Dublin
Posted Date: Sep 15 2020
We are currently hiring for a Medical Device Regulatory Compliance Manager to be based in our Dublin office. This role is reporting to the Quality Director QP Importation Operations.
This is a Permanent position.
The Medical Device Regulatory Compliance Manager ensures that supply chain processes in place to meet global regulatory requirements for medical devices. As the Legal Manufacturer's representative, this role is directly responsible for managing regular external authority inspections of the Legal Manufacturer processes. These inspections are required to maintain certification that enables medical devices to be placed on the market.
As Medical Device Regulatory Compliance Manager you will:
- Manage interactions and communications with external regulatory authorities for the PSC medical devices, i.e. Competent Authorities and Notified Bodies, to register and maintain medical device filings
- Operate quality system processes to maintain appropriate external certification for PSC medical devices
- Ensure a compliant operation is in place for Pharma Supply Chain medical devices
- Manage governance processes for Medical Device supply chains, including incident management, Quality Council and risk management
- Manage self-inspection activities and CAPA management processes covering Medical Device Team operations to support maintenance of certifications
- Ensure the Medical Device Team and associated supply chain is inspection ready and lead/host external inspections of the Legal Manufacturer
- Coordinate supply chain processes for medical devices
- Review and approve appropriate batch verification, change controls, and artwork changes relating to supplied medical devices
- Ensure deviations during production have been adequately investigated by the manufacturer and are trended, with appropriate CAPA identified
- Ensure customer complaints are coordinated and suitable technical assessment conducted
- Ensure device technical files are maintained and post-marketing surveillance processes are followed so that periodic safety update reports are completed in accordance with regulatory requirements
- Act as QMS Champion for Medical Device Team and provide oversight for QMS implementation so that GSK policies are assessed and implemented as required.
- Support QMS activities across the wider QP Importation Hub
- Science or engineering degree and significant experience in pharmaceutical / medical device manufacturing and quality operations.
- Excellent working knowledge of quality system requirements.
- Experience in quality and compliance within a manufacturing and / or development environment for medical device / pharmaceutical product supply.
- Excellent knowledge of GMP / medical device regulations.
- Demonstrated skill in managing multiple priorities.
- Experience of batch verification processes.
- Excellent oral and written communication skills.
- Capable of working in multi-disciplinary teams across Quality, External Supply, Supply Chain, Regulatory, Clinical Safety and Medical, Technical, IT and Manufacturing
- Demonstrated ability to function effectively in a matrix organisation.
- Ability to influence and negotiate at senior levels across functional boundaries.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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