Job Description
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We have an exciting opportunity for a Quality Assurance and Regulatory Affairs Manager role in a Medical Equipment Manufacturing company. The company develops intelligent wearable technology. It's searching for someone who can successfully comprehend and address customer wants and challenges while working with a small, focused team in a fast-paced startup setting.
Job Requirements:
- Working knowledge of Class I and Class II medical equipment.
- At least 5 years of expertise designing and developing medical devices is essential.
- Intellectual versatility, inventiveness, and a track record of generating successful products are all desirable qualities.
- Professional team player with a positive attitude who accepts constructive feedback.
- Ability to work both individually and as part of a team.
- Experience directing teams using digital collaboration platforms.
- Employee management experience, both digitally and abroad.
- Exceptional interpersonal and teamwork skills are required to provide direction to other members of staff.
- Capability to focus team members and partners to accomplish company deadlines.
- Excellent management, administrative, and analytical skills, as well as a keen eye for detail.
- Knowledge of medical equipment marketing channels, plans, and policies is required.
- Knowledge of QMS and ISO (13485, 14971, 60601) standards is a plus.
Responsibilities
Job Responsibilities:
- Establish QA-RA timelines and ensure that the team meets all essential milestones and deadlines (Project/Program management is responsible for overall timing and can assign some of it to "QA/RA").
- Implement an ISO13485-compliant QMS.
- Maintain a technical file for the company following the new MDR rules.
- Review and guide labeling to ensure that it complies with regulatory filings.
- Collaborate closely with the technical team to guarantee adherence to relevant standards (such as ISO 13485, 14971, and 60601) and to create an Investigative Brochure for Medical Trials.
- Submit ethics/MHRA/US FDA submissions in collaboration with the clinical team.
- Assist in the examination of marketing materials for regulatory and legal compliance.
- Conduct regulatory evaluations of customer complaints and establish regulatory reporting requirements.
- Keep up-to-date on all applicable international legislation and standards.
- Prepare regulatory documents for submission to authorities (such as the US FDA, EU, ASIA).
- Where necessary, assist in technical reports, papers, publications, presentations, and patents.
- Contribute to grant applications, fundraising, and other related endeavours.
- Develop, implement, and maintain a quality management system in preparation for ISO 13485 certification.
- As needed, assistance with all clinical work.
- Make every effort to ensure the company's overall success, particularly in terms of regulatory compliance.
- International travel will be required as needed.
- Mentor other team members in relevant areas.
- Engage in activities connected to innovation.
Referrals
If you know anyone who may be suitable for the above role, feel free to get in contact with the Mandarin Recruitment team. We will ensure a healthy referral bonus.
About Us
Mandarin Recruitment is a service that helps UK and China businesses & organisations find and source high-quality Mandarin-speaking professionals. We have unparalleled and exclusive channels to the Chinese speaking market, allowing us to be the leading organisation for specialist Mandarin recruitment.
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