Regulatory Affair Specialist

4 weeks ago

Wembley Greater London, United Kingdom Medicareplus International Ltd Full time
Job Description

Job Summary

RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly.

Responsibilities

· Responsible for maintaining and supporting the promotion of regulatory affairs and ensuring that overall regulatory compliance of the Company, is maintained.

· The position provides and contributes to regulatory solutions to business requirements and changes to the regulatory landscape.

· The position provides operational regulatory input and guidance to cross functional teams, ensuring compliance to MDD, MDR and other applicable regulatory standards.

· Furthermore, the Regulatory Affairs Specialist is responsible for the completion of regulatory submissions for product registrations and post-market surveillance (PMS) and vigilance in line with the business needs.

Accountabilities

· Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents

· Prepare submissions / regulatory compliance documents in line with agreed timeframes

· Support the post-market surveillance (PMS) and vigilance reporting requirements

· Support the generation and completion of technical documentation in line with agreed timeframes

· Hands on in the remediation of technical files with agreed timeframes

· Participate in internal or external audits

· Write or update standard operating procedures and work instructions

· Assist with International Product Registrations as required

· Support the QA function as directed

Key challenges

· Frequent contact with external contract manufacturer and suppliers

· To collate data from multiple sources, interpret and produce meaningful management reports with justified balanced recommendations

· To work to tight deadlines and manage a workload which has designated lead times

· To show initiative in problem solving by identifying and recommending solutions to problems encountered

· To maintain a personal knowledge of the current Quality Management System and regulatory requirements

Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility

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