Location: Beijing, Beijing Shi CN
Job Number: 857
At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
We are seeking a RA Specialist who is passionate about the field of imaging devices and is committed to grow with the company as we take on new emerging markets.
- 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
- Review, edit and proofread regulatory documents for submission. Track of status and progress of regulatory documentation
- Ensure compliance with authority regulations and interpretations
- Prepare responses to authority's questions and other correspondence
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
- Provide solutions to a variety of problems of moderate scope and complexity
- Organize and maintain reporting schedules for new device application
- Maintain and renew of existing registrations
- 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 requiredTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Qualifications & Experience:
- Bachelor’s degree majored in medical, pharmaceutical, biological, engineering, mechanical or related specialties
- 7+ years’ regulatory affairs working experience with 3+ years’ focusing on medical device field
- Familiar with imaging products, surgical products or IVD
- Previous work experience within a multinational and cross matrix environment
- 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
- Effectively bilingual
- 必要时作为项目组成员参与工作To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job Number: 857
Community / Marketing Title: RA Specialist
Location_formattedLocationLong: Beijing, Beijing Shi CN