杭州招聘

Responsibility:

• Ensuring that all new and existing products are registered correctly with the relevant regulatory authorities in international markets
• Planning and preparing submissions to relevant regulatory authorities (product technical files)
• Maintenance and development of regulatory status spreadsheets
• Monitoring product regulatory status and renewal of existing product registrations and evidence of compliance as necessary
• Monitoring of regulator database records, comparing to internal records to establish consistency and detect any errors
• Ensuring timely approval of product applications
• Internal quality / regulatory auditing
• Collation of data from clinical trials, reviewing trial protocols
• Liaison with entities in diagnostics / regulatory business
• Distributors
• Manufacturers
• Industry associations
• Authorised Representative
• Liaison with regulatory authorities and international customers
• Reviewing marketing material, product instructions for use and product labeling for regulatory compliance
• Keeping informed and up to date with global regulations
• Maintaining technical files and providing necessary updates to regulatory authorities
• Participating in cross-functional product development processes
• Providing regulatory assistance and advice to international sales team
• Undertaking project work as required to support corporate strategies
• Preparation of monthly reports
• Additional duties as may be required from time to time

Requirement:

• Bachelor Degree or above of Pharmaceutical diagnostics, Biological, Medical or related backgound
• Very good attention to details
• Ability to multi-task, prioritise and change focus when required
• Proven excellent written and oral communication skills
• Integrity and diplomacy
• Knowledge of regulatory requirements
• Understanding of immunoassay principles
• Understanding of statistics
• Experience in global Regulatory Affairs, especially pertaining to in vitro diagnostic medical devices (IVDs ), with demonstrated experience in product registrations in global markets
• Understanding of domestc Quality and Quality Management Systems
• Proven ability to effectively communicate with regulators

Inverness Medical Innovations Hong Kong Ltd., also known as IMIHK is part of Alere Inc., USA – a world leader in Point of Care Testing In-vitro Diagnostics. Alere Inc., USA is a New York exchange listed company with approximately $2.1 billion USD sales in 2010.

IMIHK is committed to provide our business partners with Cost-Effective solutions. These solutions will help them achieve unparallel opportunity of growth by earning a significant share of the market with our high quality products.

IMIHK is now covering ABON branded lateral flow diagnostic products in Asia Pacific, Latin America, South America, the Middle East, Africa, India, Pakistan, Russia, and parts of Eastern Europe territories.

IMIHK product portfolio mainly encompasses Drugs of Abuse, Women's Health, Infectious Diseases, Oncology and Cardiology testing. Most of our products are US FDA cleared and CE-Marked.

Alere's mission is To empower individuals with the freedom to gain greater control over their own health. To enable healthcare providers to improve clinical outcomes and lower costs. To deliver to our investors significant annual earnings growth for the next several years.

As part of Alere family, IMIHK would like to follow the company mission and provide you with better technology, better products and better health solution in today's competitive and fast growing environment.

Please visit us for more details here, www.imihongkong.com.