Job Description
48 days ago
Job Title
Associate Regulatory Manager
Job Description
In this role, you have the opportunity to
• Implement and maintain the regular activities on existing HK & GBA approvals, and accelerate compliance to HK& GBA requirements, and meet performance target.
• Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into HK, and further approval in GBA if needed .
• Communicates with relevant competent authorities, agents, distributors, and local sales offices to ensure the most efficient path to application approval.
• Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements. To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.
You are responsible for
• Provide strategic regulatory planning to fulfil business needs for HK & GBA;
• Have experience on handing MD listing and certification/ licensing for regulated products in Hong Kong, for example Irradiating Apparatus Licence and Type approval/acceptance certificate for products which can emit radiofrequency "RF"
To succeed in this role, you should have the following skills and experience
• Bachelor’s degree or above, major in medical or engineer.
• 5+ years RA experience on Medical Device, and lead team complete product listing in HK is preferred
• A comprehensive understanding of HK medical device regulations,
• Experience on how to make registration strategy to successfully register different type of medical device in an efficient, effective, and compliant manner
• Ability to organize, negotiate, and lead team in strategic discussions with internal and external partner.
• Eager to continually achieve higher target both on quality and schedule.
• Communication and influence skill in daily to solve the problem, •
• Ability on fast learning, project management
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Associate Regulatory Manager
Job Description
In this role, you have the opportunity to
• Implement and maintain the regular activities on existing HK & GBA approvals, and accelerate compliance to HK& GBA requirements, and meet performance target.
• Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into HK, and further approval in GBA if needed .
• Communicates with relevant competent authorities, agents, distributors, and local sales offices to ensure the most efficient path to application approval.
• Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements. To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.
You are responsible for
• Provide strategic regulatory planning to fulfil business needs for HK & GBA;
• Have experience on handing MD listing and certification/ licensing for regulated products in Hong Kong, for example Irradiating Apparatus Licence and Type approval/acceptance certificate for products which can emit radiofrequency "RF"
To succeed in this role, you should have the following skills and experience
• Bachelor’s degree or above, major in medical or engineer.
• 5+ years RA experience on Medical Device, and lead team complete product listing in HK is preferred
• A comprehensive understanding of HK medical device regulations,
• Experience on how to make registration strategy to successfully register different type of medical device in an efficient, effective, and compliant manner
• Ability to organize, negotiate, and lead team in strategic discussions with internal and external partner.
• Eager to continually achieve higher target both on quality and schedule.
• Communication and influence skill in daily to solve the problem, •
• Ability on fast learning, project management
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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