Regulatory Affairs Manager
Flexible or remote anywhere in the UK, Italy or Poland. Other European locations also considered.
Support the management of CE marking activities (MDD 93/42/EEC and MDR 2017/745) for medical devices from the Renal Care, Acute Therapies Medication Delivery, Nutrition and Advanced Surgery GBUs, with emphasis on regulatory compliance and life cycle strategy. Support the setting up of EU Policy and Strategy within the medication delivery and nutrition GBUs.
Essential Duties and Responsibilities
- Manage the development/alignment of regulatory policies and strategies across 5 GBUs, with special focus on the Renal Care and Acute Therapy GBUs.
- 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 - providing assessment on impact to Baxter.
- Support the Legal Manufacturer (BHSA) in its fulfillment of its regulatory responsibilities under the MDD and MDR.
- Manage the implementation of the RA management systems (incl. relevant SOPs) to ensure the regulatory requirements of BHSA are met.
- Manage the maintenance and planning activities related to CE-marking of BHSA medical devices.
- Provide direction to all Baxter Medical device legal manufacturers with regards to CE marking of medical devices.
- Support BHSA and other Baxter legal manufacturers in CE mark related regulatory activities in front of the Notified Bodies and relevant Competent Authorities.
- Degree in engineering or life sciences.
- At least 5 years of relevant experience preferably in Regulatory Affairs.
Skills and Experience
- Excellent knowledge of CE marking of medical devices (MDD 93/42/EEC and related directives and guidelines).
- Good 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 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.