QARA Expert

QARA Expert

Location: Beijing

Help us make breakthrough innovations in healthcare

If youre ready to have an impact in a career that makes a difference Mölnlycke could be your next step. Youll be helping to equip medical professionals around the world with solutions to improve outcomes for patients.

Position Purpose

Reporting to the QARA Manager Greater China.
Scope: Hong Kong Taiwan Mainland China
Responsible for regulatory affairs activities primary for Hong Kong and Taiwan while also covering part of mainland China including medical device registration lifecycle maintenance and regulatory compliance to effectively navigate a rapidly evolving regulatory landscape and support business growth and development objectives.
Drive Regulatory Intelligence (RI) activities ensuring timely monitoring analysis and implementation of regulatory developments while maintaining close alignment with Global Regulatory Affairs strategies to enable compliant and sustainable business growth.
Support the effective implementation of regulatory processes embedding regulatory compliance into cross functional operations.

What youll do

Regulatory Registration & Compliance
Manage the full regulatory lifecycle of medical devices in Hong Kong Taiwan and part of Mainland China including registration listing/filing renewal change and cancellation ensuring registrations are planned progressed and delivered in alignment with business strategy and timelines.
Provide professional regulatory assessments for products and portfolios establish registration plans and regulatory roadmaps to support business objectives product strategy and commercialization plans.
Prepare compile review and maintain high quality regulatory dossiers including technical documentation testing strategies clinical evaluation materials and QMS related documentation to ensure efficient and predictable regulatory progress and regulatory compliance.
Provide regulatory input and guidance to cross functional teams (Quality Supply Chain Marketing R&D) to ensure compliant product launch and lifecycle management.
Review and approve product labeling IFUs and promotional materials to ensure consistency with approved intended use and regulatory approvals.
Provide backup support for Quality Assurance activities as required including post-market surveillance and reporting authority queries maintenance of quality management system compliance and support for internal and external audits.

Regulatory Intelligence & Policy Engagement
Continuously monitor analyze and interpret regulatory laws regulations guidance standards and policy trends related to medical devices in Mainland China Hong Kong and Taiwan.
Evaluate the impact of regulatory changes on existing products pipeline projects and business strategies and define appropriate mitigation or implementation plans.
Communicate regulatory changes and potential impacts clearly to internal stakeholders proposing practical mitigation or implementation actions.
Ensure local regulatory positions are aligned with Global Regulatory Affairs strategy and governance.

Process Support & Compliance Implementation
Support the implementation and maintenance of country level regulatory and quality processes procedures and SOPs ensuring effective execution and compliance.
Maintain accurate regulatory and quality records and documentation in accordance with internal quality system requirements.
Assist in the standardization of regulatory and quality workflows for registration lifecycle management documentation control and authority interactions.
Participate in internal regulatory and quality training and knowledge sharing activities to enhance regulatory and quality awareness across cross functional teams.

What youll get

Competitive salary depending on experience
Annual bonus
Monthly allowance
Annual holiday plus bank holidays
Life assurance and Income protection
Genuine career longevity and professional development opportunities
Employee Assistance Programme

What youll decide

Recommend and support execution of registration pathways and submission approaches under established regulatory strategies.
Identify and escalate regulatory risks or gaps arising from authority feedback or submission activities.
Prioritize assigned registration and other regulatory activities to meet committed timelines.
Support coordination with external partners (e.g. consultants CROs testing laboratories regulatory authorities) as directed by RA management.

What youll need

Sound knowledge of medical device regulatory requirements and processes.
Ability to translate regulatory requirements into clear executable tasks and documentation.
Strong organizational and execution skills with the ability to manage multiple regulatory activities concurrently.
Effective communication skills and ability to work collaboratively with cross functional teams.
Detail oriented compliant and able to work effectively under regulatory and timeline pressure.
Bachelors degree or above in Medicine Pharmacy Biomedical Engineering Life Sciences Engineering or related disciplines.
Minimum 5 years of Regulatory Affairs experience in medical devices preferably with exposure to domestic and/or imported medical device registrations in China.
Proficiency in written and spoken Chinese with working level English reading and writing capability.
Demonstrates ownership accountability and willingness to assume increased responsibility and grow within the RA function.

Any other information

The role requires flexibility to respond to regulatory authority requests and evolving regulatory expectations.
Regular interaction with regulatory authorities and external service providers is expected.
Occasional business travel may be required to support regulatory or post market activities.

Additional Responsibilities

Participate in ad hoc regulatory or compliance projects as assigned.

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; were the number one global provider of advanced wound care and single-use surgical products; and were Europes largest provider of customised trays. Our headquarters are in Gothenburg Sweden and we have about 7800 employees around the world.