RA Assistant - IR (12 Month FTC) Remote

We are currently recruiting for an RA Assistant to join a UK based Medical Manufacturing organisation on a 12-month fixed term contract.

Role responsibilities:

The role is a key role within the business, interfacing with customers, in-country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical on a regular basis.

Due to the nature of the role you must be able to deliver to critical deadlines and manage your workload and time effectively, whilst meeting enforced regulatory timelines.

Key responsibilites:

Assist in the submission and maintenance of global regulatory approvals on behalf of the company (Wound care) to meet the requirements of the business plan.
To support regulatory submissions for new markets and maintaining registrations and licences in existing markets.
To support customer audit requests, tender requests and all general requests associated with International Registrations.
Implements the International Registrations system for the AMS Group (Wound care) with responsibility for OEM partners.
Compile and submit regulatory submissions for approval in applicable markets.
Maintain current registrations, licenses, Regulatory Certification, and submissions to ensure compliance with the latest medical devices framework in the countries registered.
Supporting and advising other functions within the business for information and registration requests.
Coordinate the preparation, review, and submit timely responses to requests for additional information from regulatory authorities on product registrations.
Support customer market registration activities, within the terms of existing contractual obligations.
Participate in and support audits/reviews by regulatory authorities and customers in regard to the International Registrations system including preparation, facilitation, and response.
Monitor relevant industry-wide International Registration activities.
Continuous improvement and development of the international registrations process
Support internal customer projects including artwork changes and new territory expansions and/or launches
Promote and demonstrate Care, Fair and Dare values in the workplace.
Promote health and safety policies in the workplace.Role requirements:

Science based degree or equivalent
Relevant experience of working in the medical device arena
Working knowledge of international regulatory requirements is preferable, but not required.
Excellent communication skills both written and verbally with employees, customers, in country agents and Regulatory Authorities.
Competent IT skill in preparing files.
The ability to influence and challenge others in a constructive way so as to deliver improvements
The ability to manage workload and time effectively
Due to the nature of the role deadline delivery is critical, whilst meeting enforced regulatory timelines

If this role is off interest to you, please get in touch on OR (phone number removed)

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