Baxter Healthcare
Location
Newbury, Berkshire | United Kingdom
Job description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
As the Regulatory Affairs Manager you will support the management of CE marking activities (MDD 93/42/EEC and MDR 2017/745) for medical devices from the Renal Care and Acute Therapies Divisions, with emphasis on regulatory compliance and life cycle strategy.
Support the activities for implementation of UK and Swiss Regulations.
Duties
• Manage the development/alignment of regulatory policies and strategies across divisions, Renal Care and Acute Therapy.
• Working with cross-functional groups to ensure the development of regulatory strategies for the CE marking of new Medical Devices in accordance with the business goals.
• Manage the development of strategic plans for submissions and authority interactions.
• Participate in regional Industry Association meetings (including MedTech EU working groups).
• Interpret existing, pending and proposed regulations/guidance documents for the CE marking, UK and Swiss Regulations – providing assessment on impact to Baxter.
• Support the Legal Manufacturers in its fulfillment of its regulatory responsibilities under the MDD, MDR, UK and Swiss Regulations.
• Manage the implementation of the RA management systems (incl. relevant SOPs) to ensure the regulatory requirements of the Legal Manufacturer are met.
• Manage the maintenance and planning activities related to CE-marking of medical devices.
• Provide direction to all Medical device legal manufacturers with regards to CE marking of medical devices.
• Support legal manufacturers in CE mark related regulatory activities in front of the Notified Bodies and relevant Competent Authorities.
Excellent knowledge of CE marking of medical devices (MDD 93/42/EEC and related directives and guidelines).
Excellent knowledge of the CE marking of medical devices (MDR 2017/745 and related directives/guidelines)
Ability to liaise with the different functions involved in the elaboration of CE-marking files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics.
Ability to interpret European, UK and Swiss regulations and guidelines and all technical product information to assure that regulatory requirements in the area of medical devices are continuously met.
Excellent interpersonal and collaboration skills and willingness to work in a challenging regulatory environment.
Excellent organisational skills including project management skills.
Strong commitment to teamwork, quality and customer satisfaction.
Excellent written and verbal communication skills in English.
Accountable for anticipating and resolving problems.
Accountable for completion of submissions in a shortest possible time-to-market.
Accountable for the compliance of submitted files with the corporate standards.
Bachelor’s degree or country equivalent in a scientific discipline
Masters and/or PhD will be an advantage.
Minimum of 5-year regulatory experience in RA or related field, including managing people or projects.
What are some of the benefits of working at Baxter?
Competitive total compensation package
Professional development opportunities
High importance placed on work life balance
Commitment to growing and developing an inclusive and diverse workforce
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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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