Responsible for strategic planning and coordination of regulatory activities to ensure continuity of existing marketing approvals and efficient approvals of new to market products. Our client is looking for a high calibre to join the team.

Client Details

Our client is an well-established medical device company, aiming to improve the health of patients across the world through their high quality medical device.

Description

• Responsible for the Regulatory Affairs so as to ensure resources are assigned to meet company goals, objectives and regulatory compliance
• Ensure compliance, QMS procedures, policies and relevant medical device standards and regulations
• Provide expert opinions on technical and legal matters associated with the registration of products in the region to internal stakeholders
• Liaise and collaborate with various stakeholders in relation to all regulatory issues
• Facilitate communications between all stakeholders in order to get medical devices registered in the region
• Liaise with all relevant distributors worldwide to ensure information flow and understanding of current processes
• Collaborate with regional leadership to support global focused business improvement activities
• Ensure timely and accurate reporting of key performance indicators in support of the regulatory metrics
• Maintain an excellent understanding of all medical device regulatory requirements
• Ensure all quality, regulatory, compliance, and product-specific requirements are met
• Perform any ad hoc duties as required

Profile

• Bachelor Degree in life science related disciplines
• 6+ years of RA experience in Medical Device industry
• Experience with the regulatory environments of global markets is preferred
• Allocates time and resources effectively and efficiently to achieve agreed outcome
• Well-organised, Ability to work under pressure
• Excellent verbal and written English and Chinese communications skills

Job Offer

A competitive remuneration package will be given to the right candidate.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Zalika Ho on +852 2848 4783.

As part of PageGroup, Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers. PageGroup operates through 155 offices in 35 countries worldwide. First established in London in 1976, we've been bringing jobseekers and employers together for more than 30 years. London listed, we opened our first Asian office in Hong Kong in 1994 and currently we have offices in all major business hubs across the APAC region, including Australia, Singapore, Tokyo, Malaysia, India, Taiwan, Shanghai, Beijing, Shenzhen, Guangzhou, Pudong and Suzhou.

So if you're looking to take your career to the next level, visit www.michaelpage.com.hk