Regulatory Affairs - Cambridge, United Kingdom - Cambridge Heartwear

Description

Regulatory Affairs


Responsibilities:

Preparation of regulatory submission for product approvals (e.g. 510k documentation to FDA).

• Provide regulatory expertise to scientists and senior management and assist with the preparation and submission of regulatory documentation.
• Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals)
• Ensure that our heartsense device comply with the regulations of the regions wherethey want to distribute them.
• Keep up to date with national and international legislation, guidelines and customerpractices.
• Collect, collate and evaluate scientific data from a range of sources.

- develop and write clear arguments and explanations for new product licences andlicence renewals.

• Prepare submissions of licence variations and renewals to strict deadlines.
• Monitor and set timelines for licence variations and renewal approvals.
• Work with specialist computer software and resources.
• Write clear, accessible product labels and patient information leaflets.
• Plan and develop product trials and interpret trial data.,

This is an exciting opportunity for an experienced regulatory affairs professional to lead a dynamic team and contribute to the success of our organization.

We offer competitive compensation, comprehensive benefits, and opportunities for professional growth.

To apply, please submit your resume and cover letter detailing your relevant experience and qualifications.


Salary:
£50,000.00-£55,000.00 per year


Benefits:

• Company pension
• Gym membership
• Work from home

Schedule:

• Monday to Friday

Experience:

Regulatory Affairs: 3 years (required)


Ability to Commute:

• Cambridge, CB4 0WG (required)

Ability to Relocate:

• Cambridge, CB4 0WG: Relocate before starting work (preferred)

Work Location:
Hybrid remote in Cambridge, CB4 0WG

Expected start date: 04/09/2023