Senior Regulatory Affair Manager
Location: Beijing, Beijing Shi CN
Job Number: 990
Job Title: Regulatory Supervisor
Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.
There’s never been a more exciting time to join us.
Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful.
Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
We are headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues.
We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. There has never been a more exciting time in our company’s history. Visit our website to learn more about the many career opportunities we have available today.
Hologic has China commercial organization with headquarter in Beijing. We aim to build the China Organization into an exciting place to work and grow professionally.
Key Responsibilities include:
• Evaluate product registration strategy, cost, timeline, and registration risk based on acknowledged information to support business registration decision.
• Establish, maintain and execute appropriate registration plan on the responsible pipeline, based on project priority and lead time.
• Forecast and maintain an appropriate registration project budget plan to the responsible pipeline.
• Take over the whole procedure of registration, including sample ordering, testing, dossier preparation, submission, evaluation and license obtaining.
o Review, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation.
o Ensure compliance with authority regulations and interpretations.
o Prepare responses to authority's questions and other correspondence.
o Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
o Provide solutions to a variety of problems of moderate scope and complexity.
o Organize and maintain reporting schedules for new device application.
o Maintain and renew of existing registrations.
o Involved in related product inspections and coordinate with international teams to solve related issues.
• Coordinate and organize workshops between the company and authorities on the purpose of facilitating product registration or shaping regulation/technical guidance establishment, as well as contribute in constructive influence.
• Assist in preparation and review of labeling, SOPs, and other departmental documents.
• Participate as an active team member of project teams as required.
Qualifications & Experience
• Bachelor above degree majored in medical, pharmaceutical, biological, engineering, mechanical or related specialties.
• More than 3-5years of R&D experienc
• Familiar with imaging products, surgical products or IVD preferred
• Working background in MNCs preferred
• Good communication and interpersonal skills
• Strong attention to details, be very careful and responsible
• Problem solver, identifies problems and solves them proactively, be creative in thinking of alternate solutions to problems.
• Fluent English (verbal and written forms)
There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care. Hologic believes that people are the greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.
The Science of Sure.
Job Number: 990
Community / Marketing Title: Senior Regulatory Affair Manager
Location_formattedLocationLong: Beijing, Beijing Shi CN