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Regulatory Affairs Manager

Medtronic
Watford City, ND 58854
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Regulatory Affairs Manager

Location:

Watford, Hertfordshire, United Kingdom

Requisition #:

200007QL

Post Date:

Dec 23, 2020


**Careers that Change Lives**


In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.


**A Day in the Life**


As a Regulatory Affairs Manager for UK and Ireland, you are responsible for ensuring the smooth running of activities related to regulatory compliance with UK and European regulations, as well as providing regulatory expertise within the projects in which you are involved.


The Regulatory Affairs Manager 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 RA role. It will include liaising and advising all businesses and functional units within Medtronic UK and Ireland region in respect to Regulatory Affairs.


**Responsibilities**


As a Regulatory Affairs Manager your main responsibilities will involve:


+ Manage the regulatory team in charge of all related activities fro UK and Ireland: post-market surveillance, regulatory review of promotional materials, registrations andsubmissions to authorities, RA support to business.

+ Ensure regulatory new requirements monitoring and impact assessment, identify and communicate its impacts within the organisation, and recommend change in local procedures to ensure compliance. Keep and maintain knowledge of European and UK regulatory quality aspects.

+ Provide RA activity reports to senior Management as well as RA expertise to the regions business and functional units

+ Correspond and liaise with Regulatory and Quality contacts in EMEA and Corporate to ensure Regulatory Quality requirements for the region are met efficiently.

+ Leads or compiles all materials required in submissions and annual registrations.

+ Directs or performs coordination and preparation of document packages for regulatory submissions, internal external audits and inspections.

+ Establish, develop and maintain working relationships with international regulatory teams, relevant competent authorities and the trade associationon defined matters.

+ Responsible for Product Field Safety Corrective Actions (FSCA) in the region, including submission, and their efficient and timely execution, including to plan closure as per EMEA region and Corporate plans

+ Post Market Surveillance (PMS) activities in the region to enable the EMEA RA and Quality operations to meet their reporting obligations to Regulatory Agencies

+ Be a point of contact for the UK and Ireland Regulatory Agencies in respect to Post market and registration activities

+ Develop and execute local RA initiatives/activities in line with Corporate and EMEA region and Quality requirements

+ Provide training and education on Regulatory Affairs topics both internally and externally as required.

+ Escalate RA and Quality issues to senior management level ensuring awareness


**Must Haves**


+ Successful management experience

+ Working solid experience in regulatory affairs position in medical devices industry

+ Strong expertise in UK/IRL and European regulations

+ Rigorous, with analysis and strategic thinking skills

+ Organizational project management skills, good communication interpersonal skills

+ Collaborative and positive spirit, adaptability in complex organizations


**Nice to Haves**


+ Advanced standard of education (Bachelors degree or similar).

+ Experience in working with multiple business stakeholders across a matrix environment


**Your Answer**


Is this the position you were waiting for? Then please apply directly via the apply button!


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.


Lets work together to address universal healthcare needs and improve patients lives. Help us shape thefuture.


Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.


At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it is the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us, and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer your unique perspectives, talents and contributions we can live up to the promise of our Mission
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2020-12-25 Expires: 2021-02-05
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Regulatory Affairs Manager

Medtronic
Watford City, ND 58854

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