Regulatory Product Manager - Medical DevicesSalary Guide: £40,000 pa + Excellent BenefitsHarlow, Essex
A Regulatory Product Manager with detailed knowledge of Medical Device Regulations is
required by a
leading manufacturer that develops chemical technology for the treatment of breathable gases.
The Regulatory Product Manager will ensure that Company meets the stringent legal and regulatory requirements. To undertake the oversight and review of all legislation and regulatory requirements for medical products, with respect to MDD 93/42/EEC, US FDA 212 820 QSR, CFDA No. 650, and its migration to MDR.Responsibilities & Duties:
Knowledge & Experience:
- Monitor European and UK regulation changes & recommend policy & advise actions (eg MDR, ISO 13485, poison centre notification)
- Responsible for the management and maintaining compliance to of accreditation ISO 9001 and ISO 13485 certification.
- Management of the update of all BQMS processes to ensure compliance.
- Main point of contact for product hazard & legal compliance
- Maintenance & generation of compliant SDS
- Maintenance & generation of compliant labels
- Support the new product application process with regard to medical device submissions to various countries regulatory bodies
- Maintenance & generation of other supporting product documentation
- Management of REACh (and UK equivalent) and its implications
- Participation in NPI to ensure that new or changed products or sales to new regions are compliant
- Chemistry, product stewardship or chemical engineering degree or equivalent
- Significant experience within a medical device/chemical/manufacturing business in product stewardship
- Extensive knowledge of the management of medical device legislation
- Excellent understanding of REACh (&UK equivalent) and its obligations
- Ability to interpret and summarise regulations and present issues to leadership
- Confident & Competent IT skills including MRP
Salary Guide: £40,000 pa
Location: Harlow, Essex / Hertfordshire border - Free on-site car parking