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.
Responsibilities:
- 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
Responsibilities:
- 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 do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
Who do we look for?
People who are passionate about what we do.
People who are open minded to evolving the way we work.
People who can work together to transform outcomes and change lives.