QARA Manager, Greater China
Location: Shanghai
If you’re ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You’ll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you’ll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose.
We're seeking QARA Manager to lead our regional Quality and Regulatory Affairs strategy in Great China.
Reporting to the QARA Commercial Director (APAC & MEA), this key leadership role covers Mainland China, Hong Kong and Macau, and is part of the regional QARA Commercial Leadership Team. The role will lead the Greater China QARA organization, drive implementation of regulatory updates, develop a sustainable RA and product registration roadmap, ensure full compliance with standards, maintain compliant distributor and sales agent agreements, and resolve local regulatory issues.
What you'll do
• Lead and develop QARA China team to support the company’s goals; collaborate closely with local commercial leaders
• Drive local quality professionals in the implementation, maintenance and improvement of the global and local QMS
• Drive cross‑functional efforts to build compliant manufacturing processes in China, ensuring full alignment with regulatory expectations from the start of operations.
• Accountable for strategic planning, regulatory filings and product registration maintenance are fully integrated into 3DX
• Develop and deliver training on quality tools and processes in at the commercial sites
• Oversee registration of existing products and execute registrations and obtains marketing approval for new/modified device applications
• Ensure regional FSCA reporting, incident reporting and FSCA handling comply with global procedures and local regulations
• Prepare for and participate in audits, and implement corrective actions
• Accoutable for local cost centres, overseeing the total FC for QARA China.
What you'll need
• Bachelor's degree in life-science or another relevant scientific discipline, or equivalent combination of experience and education.
• A minimum of 10 years within an international medical device company, working within QA and/or RA, preferably a minimum of 5 years in a leadership position.
• Deep understanding of regulatory requirements, including ISO 9001, ISO 13485, MDR, and regional standards.
• Extensive knowledge of China’s manufacturing regulatory environment, with a proven track record of ensuring full compliance in local operations.
• Excellent communication and proven ability to lead cross-functional teams and work with internal stakeholders.
• Good experience with regulatory authorities’ inspections.
• Fluent in English and Chinese and used to work in a multicultural environment.
ABOUT MOLNLYCKE
Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.
We specialise in:
Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients.
Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves.Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.