Senior Regulatory Affairs Officer

SENIOR REGULATORY AFFAIRS OFFICER

Brightwake Ltd. are an innovative medical device company specialising in the design and development of “Advanced Wound Therapy” and “Negative Pressure Wound Therapy” dressings and electro-mechanical medical devices. Due to steady growth Brightwake now have a requirement for a Senior Regulatory Affairs Officer.

Reporting directly to the Head of Regulatory Affairs the role will provide experience and support to the Regulatory Affairs department.

Key responsibilities include;

·  Taking ownership of business critical regulatory projects, and ensuring compliance is achieved at each stage, and providing the appropriate guidance on regulations, standards and directives.

·  Ensuring regulatory systems, such as regulatory database (including UDI) / trackers are implemented and up to date.

·  Preparing and reviewing labelling / packaging text (promotional reviews).

·  Representing Regulatory Affairs for assigned design projects.

·  Preparing, reviewing and making the necessary impact assessment on regulatory status of proposed changes to approved medical devices and signing off change control.

·  Provide guidance on territory specific requirements where necessary (including FDA, Canada, Australia, China and Japan).

·  Actively participate and provide guidance on product development lifecycle, advising on regulatory pathways.

·  Assist in maintaining working knowledge of changing regulatory requirements and potential impact on business.

·  Assist in maintain awareness of global quality management system requirements and potential impact on existing and pending registration activities.

·  Ensuring customer feedback is assessed for impact on risk management and product design.

·  Coaching and mentoring other members of the Regulatory Affairs team.

The successful candidate will be ideally educated to Degree level having solid experience of regulated industries including Medical Devices. You must have knowledge of ISO 13485, ISO 14971, 21CFR 820 and it would be desirable if your knowledge extended to ISO 9001, ISO 60601 and ISO 14155. You must have the ability to project manage a number of projects simultaneously, to write reports including complex information and have the confidence and skills to present information. As the role will include coaching and mentoring some of the team the ability to demonstrate this skill is essential.

To apply for this role please send a covering letter or CV clearly stating your current salary to:

Lynn Brownsword

HR Manager

Email:

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