Senior Regulatory Affairs Associate Remote
1 month ago
**This is an initial 12 month contract with strong possibility of extension.**
The purpose of this role is to support the management of CE marking activities (MDD 93/42/EEC and MDR 2017/745) and UKCA marking activities (UK Medical Device Regulations 2002) for medical devices, with emphasis on regulatory compliance and life cycle strategy.
**Role**:
- Support the development/alignment of regulatory policies and strategies across all GBUs
- Working with cross-functional groups to ensure the development of regulatory strategies for the CE and UKCA marking of new Medical Devices in accordance with the business goals.
- Support 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 regarding MDD, MDR and UKCA - providing assessment on impact to the client.
- Supports the Legal Manufacturer in its fulfilment of its regulatory responsibilities under the MDD, MDR and UKCA.
- Support the implementation of the RA management systems (incl. relevant SOPs) to ensure the regulatory requirements are met.
- Support the maintenance and planning activities related to CE and UKCA marking of medical devices.
- Provide direction to all the client’s Medical device legal manufacturers with regards to CE and UKCA marking of medical devices.
- Support the client and other legal manufacturers in CE and UKCA mark related regulatory activities in front of the Notified Bodies, UK Approved Bodies and relevant Competent Authorities.
**Requirements**:
- Degree in engineering or life sciences
- Around 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance R&D or System, Standard Compliance testing in a medtech company.
- Good knowledge of CE marking of medical devices. (MDD 93/42/EEC and related directives and guidelines).
- Ability to liaise with the different functions involved in the elaboration of CE files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics.
- Ability to interpret European and UK regulations and guidelines and all technical product information in order 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 organizational skills including project management skills.
- Strong commitment to teamwork, quality and customer satisfaction.
- Excellent written and verbal communication skills in English.
- Cultural sensitivity.
- 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.
- Open to innovation and risk taking.
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