Regulatory Affairs Manager (China) Job at 360 Resourcing Solutions (Shanghai)

Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world. The Regulatory Affairs Manager (China) will develop regulatory strategies and lead product registrations in China. They will work closely with multiple stakeholders including the Managing Director (Biocomposites Shanghai), Regulatory Affairs Projects Manager (Biocomposites Ltd, UK), Chinese consultants and NMPA.

Job Responsibility

Lead the creation of submissions, registrations and medical device reporting for new and existing products in China (and other APAC territories as required)
Communicate with and coordinate consultants and regulators in China to plan, facilitate and execute consultation meetings, product applications and to maintain products on market
Develop strategies and plans to register products in China
Compile and maintain technical documentation for product registrations in accordance with Chinese and other specified country requirements
Prepare and review product documentation in the Chinese language
Lead the preparation and review of materials for pre-submission consultations with NMPA including briefing books and powerpoint presentations
Travel to NMPA and/or Test Laboratories to facilitate product registration as required
Research and consult on regulatory requirements to register new or changed products in China
Report, assess and communicate changes in regulations
Guide the organisation to maintain compliance with the latest NMPA law and regulations relating to medical devices
Translate a variety of documents from internal and external stakeholders including technical documents, regulations, briefing books and consultation meeting notes from Chinese to English and from English to Chinese, as required
Coordinate & manage regulatory change controls, quotations, purchase orders, invoices, notarisation/legalisation of documents and related administrative tasks
Create and maintain regulatory procedures, as required
Participate in internal and external audits, as required
Support post-market surveillance activities, as required
Act as delegate for activities falling under the remit of the Regulatory Affairs Projects Manager
Act as mentor for junior regulatory staff members

Requirements

Bachelor’s Degree in a life science or equivalent
Minimum 8 years’ experience within the medical device industry
Experience of pre-submission consultations with NMPA
Experience of medical device submissions to NMPA
Proven knowledge of medical device regulation and applicable standards and guidance documents in China
Fully proficient in both Chinese and English (written and oral)
Strong written and verbal communication skills with ability to convey matters clearly and to express complex issues in both English and Chinese
Exceptional teamworking skills
Strong sense of initiative and self-motivation
Excellent interpersonal and communication skills when liaising with internal and external stakeholders from varying disciplines and cultures
Ability to translate technical text from Chinese to English and from English to Chinese
Proficient in the use of Microsoft Office

What we offer

Competitive salary and benefits
We grow talent
One Biocomposites – team spirit & engagement

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Regulatory Affairs Manager (China)

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