Job Description - Regulatory Affairs Manager - Johnson & Johnson MedTech (2506232615W)
Johnson & Johnson MedTech is recruiting for a Regulatory Affairs Manager , located in the United Kingdom Or Republic of Ireland (UK/IRE), to be part of the team in this dynamic dual legislative environment.
Role Purpose and Summary
This role will involve monitoring of the Regulatory Environment and fostering feedback to relevant partners, deployment of activities to ensure local regulatory compliance. Responsible for Regulatory Affairs strategy for Medical devices, Medicines and Human Tissues as defined by the product portfolio. Co-ordinate the activities of the local team to ensure timely compliance and innovation of processes and assist and deputise as the UK Responsible Person on behalf of Johnson & Johnson Legal Manufacturers.
Key Responsibilities
Monitoring of and deployment of local regulatory requirements, advising appropriate partners.
Coordination of the work of the team in deploying J&J standard requirements to project timelines.
Interprets regulatory requirements and applies them to RA strategies and impact assessments, on changes to products, business models, licences considering impact to HCPS and patients.
Takes ownership and responsibility for decisions regarding work processes or operational plans and schedules.
Responsible for institutional relationships with external organisations.
Ensure company compliance in all activities related to Regulatory input.
What you will be doing
Deployment of local regulatory requirements.
Monitoring local Regulatory Environment and feed-back to relevant partners.
Coordination of the deployment of J&J standard requirements.
Ensures organization compliance with all applicable regulations and J&J policies.
Interprets new regulatory requirements and determines strategies.
Makes decisions regarding work processes or operational plans and schedules.
Responsibility of Institutional relationships – with CA/EC in collaboration with corporate GA&P.
Performs Impact assessments of regulatory changes on products, business/licenses and patients/HCP.
May manage internal and contingency RA resources.
Qualifications
Who we are looking for
Education:
Degree of Pharmacist or Scientific Degree or Law Degree or equivalent Experience and Skills: UK Regulation MDD Directive & MDR Regulation Human Tissues and Cells Directive AI legislation Preferred: Experience of sophisticated project management Experience of working with Notified Bodies Experience of supporting Tenders High degree of initiative. Outstanding collaboration to cultivate the strength of a network Communication and negotiation skills. Open minded, listens to others Able to handle complexity organization structures At ease in an international environment. Diplomacy Other: 10% Travel What type of mark will YOU make? By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. What’s in it for YOU ? It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.
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Degree of Pharmacist or Scientific Degree or Law Degree or equivalent Experience and Skills: UK Regulation MDD Directive & MDR Regulation Human Tissues and Cells Directive AI legislation Preferred: Experience of sophisticated project management Experience of working with Notified Bodies Experience of supporting Tenders High degree of initiative. Outstanding collaboration to cultivate the strength of a network Communication and negotiation skills. Open minded, listens to others Able to handle complexity organization structures At ease in an international environment. Diplomacy Other: 10% Travel What type of mark will YOU make? By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well and your mind. What’s in it for YOU ? It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.
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