Beijing
JJVC is recruiting for a RA Manager, located in Beijing.
Ensure creation and execution of regulatory strategies to support business growth in the China market.
Key Responsibilities:
Class II & III new, change, renewal and filing registration Accountabilities：
1. Directs both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, renewals, copy clearance, global LCM labeling support, and external environment surveillance).
2. Oversees the creation of global regulatory product development strategies and preparation/submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements.
3. Ensure compliance with product post-marketing approval requirements.
4. Interacts with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Participate in applicable trade association/industry working groups to influence policy in alignment with business strategies.
5. Anticipate emerging issues and develop solutions.
Other Duties
1 Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
2 Integrate regulatory considerations into the corporation’s global product entry and exit strategy
3 Recruit, develop, and mentor regulatory professionals
4 Communicate application progress to internal stakeholders
5 Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance
6 Represent regulatory affairs in product recall and recall communication process
7 Manage processes involved with maintaining annual licenses, registrations, listings, and patent information
8 Labelling Accountabilities: Review, copy clear and maintain JJVC product labelling including local carton and Instructions for use in compliance with country specific regulation
Qualifications & Education:
At least Bachelor’s Degree or equivalent experience, preferably majored in scientific, technical, or engineering; MD is preferred
Experience and Skills Required:
Minimum 6 years experience in medical device industry with hands on NPI experience obtaining regulatory approvals for medical devices
Skilled in establishing collaboration with internal and external partners, successfully influence functional business partners
A strong self-learner and Critical thinking with hands on knowledge and skill
Proficient communication and social skills
Sense of collaboration
Preferred:
Experience in the field of class III active medical devices
Other:
Language Requirements: Proficient speaking in English
Travel Requirements: 10%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disabili
ty.