Quality & Regulatory Affairs Manager

Regulatory Affairs         ·        Watford, Hertfordshire, United Kingdom        ·         Full time

Locations: Watford, Hertfordshire, United Kingdom

Job ID: 23000801

Job Description

Careers that Change Lives

Bold thinking. Bolder actions. We are Medtronic.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

As a Quality & Regulatory Affairs Manager for UK and Ireland, you are responsible for ensuring the smooth running of activities related to regulatory compliance with UK and the EU, as well as providing regulatory expertise for the projects in which you are involved. You will be responsible for the execution and maintenance of UKRP, Human Tissues import license and BioPhama import license activities for Medtronic Ltd. The Quality & Regulatory Affairs Manager for will be expected to establish, develop, and maintain working relationships with the wider international Regulatory Teams, geographies, and Regulatory Agencies relevant to the UK and Ireland to deliver the QRA role. This will include liaising and advising all businesses and functional units in the UK and Ireland with respect to Regulatory Affairs & Quality.

A Day in the Life

• Manages the UKI regulatory team & develops the RA team’s skills,
• Responsible for execution and maintenance of UKRP, Human Tissues import license and BioPhama import license activities for Medtronic Ltd (UK) and main contact for Regulatory Agencies in the region (including Human Tissue Agency for the UK HT import license and MHRA for the UK pharma Wholesaler license),
• Quality Management Representative as per ISO13485,
• Keeps abreast of regulatory procedures and changes, ensure regulatory new requirements monitoring and impact assessment, inform EMEA and Enterprise levels of the changes and recommend change in regional & local procedures to ensure compliance,
• Leads or compiles all materials required in regulatory submissions and annual registrations,
• Leads license renewal (in collaboration with Human Tissues Designated Individual and Pharma RP/RPi),
• Coordinates internal & external audits and inspections, on medical devices, pharma and human tissues activities,
• Is accountable for Post Market Surveillance (PMS) activities in the UK/I, specifically Product Field Safety Corrective Actions (FSCA), including notification, efficient and timely execution, and reporting,
• Deploys the enterprise QRA strategy in UKI (projects and initiatives),
• Establishes, develops, and maintains working relationships with international regulatory teams, relevant competent authorities, and the trade association on defined matters,
• Provides or directs training and education on Regulatory Affairs topics both internally and externally.

Must Haves

• Solid working experience in regulatory affairs & quality position in medical devices industry (7 years of relevant experience with 5+ years of managerial experience),
• Successful management experience, people developer,
• Excellent communication & interpersonal, Influence skills,
• Hands-in attitude, rigorous, with analysis and strategic thinking skills,
• Organizational & project management skills,
• Collaborative and positive spirit, adaptability in complex organizations.

Nice to Haves

• Experience in working with multiple business stakeholders across a matrix environment,
• Experience in human tissues regulation and/or medicines regulation.

We Offer

We offer a competitive salary and benefits package to all our employees:

• Flexible working environment,
• Annual Incentive Plan % depending on company results,
• Pension scheme and group discount on healthcare insurance,
• Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract,
• Employee Assistance Program and Recognize! (our global recognition program).

About Medtronic

When joining Medtronic, you’ll become part of a company that is recognized as a Top Employer in multiple countries throughout Europe. Every day we strive to engineer the extraordinary all the while delivering excellent people experiences and practices benefitting you and your career. Read more about Top Employers. 

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.

In everything we do, we are engineering the extraordinary.

Our commitment

Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.

We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.

Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.

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