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