Product Compliance Officer - Medical Devices in Newcastle upon Tyne

Location: Newcastle upon Tyne

Contract: FTC

We're on the lookout for a Product Compliance Officer to join our team on a fixed term basis! The primary purpose of the role is to ensure that all products comply with relevant international regulations and standards across a selection of regions/countries (including North America, Europe and Asia). In addition, this role is accountable for all medical device regulatory matters.

What you will be doing:

• Responsible for ensuring that all medical devices and general products (whether designed and developed or sourced) comply with relevant international standards, directives and regulations, covering the product itself as well as labelling, warning and instructions.
• Lead on the regulatory strategy planning and execution for all medical devices.
• Liaising with the Design and Development teams to evaluate medical product concepts and ensure they comply with relevant international standards, directives and regulations.
• Conducting product risk assessments to identify any safety hazards at the necessary stages of a product life cycle.
• Inputs to lifecycle management development processes.
• Liaising with external test houses to identify test requirements and associated costs.
• Ensuring all product compliance and technical file documentation is maintained and up to date.
• Keeping up to date with all relevant product standards, regulations and directives, while ensuring any necessary changes are managed.
• Accountable and responsible for the creation, management and maintenance of medical device technical documentation, including verification reports, risk assessments, and quality management system records and other CE/UKCA marking activities, ensuring compliance with industry standards to ISO 13485.
• Accountable and responsible for all PRRC activities for medical devices.
• Take direct ownership of relevant Medical Quality Management System processes and ensure continued compliance by managing the ISO 13485 Quality Management System including leading on the Medical Quality Management Reviews with senior staff.
• Support with ISO 19001 and 14001 internal and third-party audits when needed.
• Accountable for the ISO 14971 Medical Product Risks, to identify any safety hazards at the necessary stages of a product life cycle and accountable for ensuring the safety of all products placed on the market.
• Establish, develop and manage external relationships with relevant international regulators/market surveillance authorities including notified bodies.
• Act as the regulatory liaison and primary contact person for all Medical regulatory bodies including MHRA, FDA, TGA and EUDAMED.
• Maintain licenses of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance.
• Act as the Subject Matter Expert for global medical device regulatory requirements and be responsible for providing expert guidance to the wider teams.

What skills and experiences you’ll need to ace this job:

• Experience working in the below industries in a Quality/Technical/Compliance role:
• Consumer Products/Household electricals
• Juvenile Products/Toys
• Textiles/Clothing
• Proven experience in a Quality Assurance role.
• Experience in Product Compliance (Consumer goods).
• Understanding of international product safety legislation, such as the Medical Device Regulations, General Product Safety Directive, EMC Directive, Low Voltage Directive, RoHS Directive, REACH.
• Experience with juvenile product standards (EN 71/ASTM F963).
• Strong communicator at all levels.
• Good Project Management skills.
• Commercial acumen for making business decisions.
• Household electricals (IEC 60335).
• Knowledge of MDD/MDR/21 CFR Part 820.
• Experience with ISO 14971 and ISO 13485 (Medical Quality Management Systems Qualification and Internal Auditor Training).
• Experience of medical device regulations and directives, single audit programme and FDA training.