Assistant RA Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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%