RA Manager, China

RA Manager China

Location Shanghai

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.

Purpose of Position

• Reporting to the QARA Manager Greater China.
• Scope: R&D projects initiated by mainland China.
• Responsible for providing regulatory oversight and execution throughout the product lifecycle including early R&D phases design development product finalization and product registration activities.
• Ensure regulatory compliance of product development activities in China by supporting design control risk management clinical/regulatory strategy and submission planning in alignment with HQ requirements.
• Develop and execute regulatory strategies pathways and registration plans for new products and modifications to secure market authorization in China and other target markets as needed.
• Drive Regulatory Intelligence (RI) activities ensuring timely monitoring analysis advocacy and implementation of regulatory developments while maintaining close alignment with Global Regulatory Affairs strategies to enable compliant and sustainable business growth.
• Contribute to the implementation and optimization of country-level regulatory processes assist to maintain compliance consistency and operational effectiveness and support business teams in understanding and applying regulatory requirements through standardized workflows and training.

What youll do

Product Development Regulatory Leadership & Strategy

• Provide regulatory leadership throughout the product development lifecycle partnering with R&D and Quality teams from early concept through design transfer to ensure regulatory requirements are embedded by design.
• Translate regulatory requirements into design control inputs development plans and actionable guidance to enable compliance by design.
• Assess regulatory feasibility of new product concepts technologies design changes and manufacturing transfer activities identifying risks and mitigation strategies early.
• Define and drive China regulatory strategies and registration plans for new products product modifications and renewals aligned with development milestones and business objectives.
• Advise on submission pathways testing requirements clinical or alternative evidence strategies and applicable standards to support efficient market authorization.

Registration Execution & Technical Documentation Governance

• Conduct preparation submission and lifecycle maintenance of NMPA regulatory dossiers including technical documentation type testing coordination and deficiency response activities.
• Support product finalization and registration readiness by ensuring compliance with local testing standards conformity clinical evaluation strategies and regulatory documentation requirements.
• Ensure development and submission deliverables including risk management documentation labeling IFU and technical files meet China regulatory requirements.
• Maintain accurate and controlled regulatory records product master files dossiers and certificates.

Compliance Support & Regulatory Intelligence

• Support audits inspections and regulatory authority inquiries by providing compliant documentation and sound regulatory interpretations.
• Contribute to regulatory intelligence activities relevant to product development by tracking regulatory changes standards updates and industry practices; Translate regulatory changes into clear impact assessments and practical development or documentation actions to maintain ongoing compliance.
• Ensure that regional regulatory approaches positions and interpretations are aligned with Global Regulatory Affairs strategies governance models and submission principles.
• Participate in or lead regulatory advocacy and industry engagement activities contributing company perspectives to the development of regulations standards and guidance where appropriate.

Process & Capability Development

• Support the development implementation and continuous improvement of country-level regulatory processes procedures and SOPs helping to maintain consistency compliance and operational efficiency across regulatory activities.
• Assist in the standardization and optimization of regulatory workflows related to product registration lifecycle management documentation control and interactions with regulatory authorities.
• Coordinate and support regulatory training programs and targeted knowledge-sharing activities for cross-functional teams increasing regulatory awareness and facilitating the practical application of compliance requirements in business processes.

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

• Determine regulatory pathways submission strategies and evidence requirements for products under development.
• Decide registration approaches dossier structure and authority response strategies for NMPA submissions.
• Own decisions on regulatory impact of product or manufacturing changes and required mitigation or escalation.
• Regulatory risk assessments and escalation recommendations.

What youll need

• Strong understanding of China NMPA regulations standards regulatory and clinical pathways and product lifecycle management.
• Excellent communication and coordination skills for working with R&D Quality Clinical Marketing Supply Chain and global QARA teams.
• Ability to interpret regulatory requirements pragmatically and provide actionable guidance to project teams.
• Strong analytical and problemsolving skills in regulatory and technical documentation.
• Ability to manage multiple registration projects and timelines in a structured manner.
• Proactive detailoriented and able to collaborate effectively across functions.
• Bachelors degree or above in Medicine Pharmacy Biomedical Engineering Life Sciences Engineering or related disciplines.
• Minimum 8 years of Regulatory Affairs experience in medical devices experience with NMPA Class III device end-to-end process is a must.
• Proficient in written and spoken English and Chinese.
• Experience supporting design control or R&D regulatory guidance is required.
• Familiarity with postmarket change management processes and regulatory impact assessment.

Any other information

• The role requires agility in responding to frequent regulatory changes and evolving regulatory expectations.
• Regular interaction with regulatory authorities and external stakeholders is expected.
• Occasional business travel may be required for regulatory meetings or project support

Additional Responsibilities

Participate in adhoc 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.