Regulatory Affairs Product Manager

Description:

Premier Work Support are excited to be recruiting for a Regulatory Affairs Product Manager for a prestigious Manufacturing client based in Tadworth.

This role will be working on all sectors (Family Care, Baby & Childcare and Adult) for the client. These best-selling ranges are sold throughout the EMEA region. Ensure participation in project teams developing/launching new products to define global, regional and national PPE regulatory requirements and develop regulatory strategies and assessments to ensure successful achievement of business objectives.

Responsibilities of the role:

PPE Regulatory experience is essential.
Having the ability to quickly understand the PPE range sold by the company across the EMEA, NA & LAO regions.
Navigating the buying organisation during the transition period.
Having the ability to collaborate and communicate across the buying organisation to ensure continued compliance.
Have the insight to problem-solve proactively on regulatory and associated quality issues.
Comply with company policies, internal controls and global regulations.
Review & submit accurate regulatory submissions to secure timely approvals in support of business initiatives.
Follow company Regulatory Intelligence process to monitor the development of regulatory changes and communicate potential business impact to senior management.
Lead regulatory agency engagement and respond to inquiries to ensure that registrations renewals and approvals are granted without delay.
Participate in review of products sold in NA that are less regulated to ensure boundary adherence.
Provide regulatory support for post market assessments & reporting.
Assist in the resolution of regulatory and/or quality issues including providing recommendations for corrective action.
Ensure required Declarations of Conformity are created and posted as required for CE & UKCA marked products.
Provide regulatory support as required for planned or unplanned audits.
Provide advice regarding compliance with FDA and Health Canada Quality System and GMP requirements, as required.Qualifications/Experience Required:

A broad technical background is required; preferably a graduate level degree with 5 -7 years of relevant experience, or a minimum, a bachelor's degree within a major scientific discipline and 7-10 years of relevant technical experience.

CE & UKCA certification and maintenance for Category I, II & III products
US FDA medical device products including maintenance of regulatory registrations and listings including but not limited to NIOSH Approvals, FDA 510(k)
Health Canada device submissions
Knowledge of QSR/GMP regulations