Johnson & Johnson Careers
Regulatory Affairs Manager - Global product registrations
Requisition ID: 1805674199W
LifeScan is dedicated to best serving the needs of the diabetes community and we recognize the importance of supporting global and national partnerships. In addition to providing monetary and product support, our goal is to increase awareness by teaching people with diabetes and their families that diabetes complications can be reduced with proper diabetes management. At LifeScan, we believe we can make a bigger difference by working together.
New breakthroughs am essential to the future of diabetes care. LifeScan is already working to bring you the next important advances in diabetes care. Our development of new technology and manufacturing of innovative blood glucose monitoring devices has made our OneTouch® systems the #1 most prescribed brand by Endocrinologists and Primary Care Physicians. These kinds of advances will continue to help eliminate barriers and let patients live life how they choose.
Partnering with regional regulatory leads and business unit leaders to develop and execute effective global regulatory registration strategies for diabetes related medical device products. Leading a small team to partner with Regulatory affiliates for the execution of the registration plan.
- Developing product registration strategies to support timelines for new and modified products.
- Liaising with regional leaders and local in-country regulatory resource (LIRR) to understand global product registration (GPR) requirements ensuring compliance with changing requirements.
- Developing and maintaining a detailed GPR plan product registrations and license renewals.
- Managing a small business unit team with responsibility for sourcing registration documents and supplying to LIRR for the creation/submission of local product registration dossiers in accordance with the GPR plan.
- Capturing and evaluating global registration metrics to monitor Key performance indicators and improve effectivity and efficiency.
- Providing regulatory leadership to respond to health authority questions during the local registration approval process and resolve issues as they arise.
- Manages relationship with third party service provider for legalization of documents and provision of Certificates of Free Sale.
- Provides people leadership to direct reports, including goal setting, prioritization, mentoring, professional development and performance management.
- Providing Regulatory Affairs support during internal and external audits.
- Assisting in the development of standard methodologies for Regulatory Affairs processes
- Representing Regulatory Affairs on cross-functional project teams as required
DO YOU HAVE THE FOLLOWING SKILLS, EXPERIENCE AND EDUCATION?
- Ability to understand complex situations and develop strategic plans to meet business needs
- Ability to think creatively to provide solutions
- People development experience and mentoring skills
- High attention to detail
- Excellent written and verbal communication skills
- Ability to work reciprocally as part of a multi-tasking team
- Are you Assertive and focused?
- You have a degree (or equivalent) in a scientific field
- Knowledgeable of ISO 13485 requirements.
- Technical experience obtained in a R&D setting
- At least 5 to 10 years of medical device, diagnostic or related industry experience in regulatory affairs.
- Proven experience in global product registrations.
- You have knowledge and understanding of EU and international medical device regulations.
- Excellent analytical capability
- You have an Independent problem-solving ability
- Ability to interface successfully with all levels of internal organization and external regulatory authorities.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Lifescan Scotland Limited (form. Inverness Medical (7691)