Johnson & Johnson Careers
Regulatory Affairs Manager, Compliance & Sustaining
Requisition ID: 1805675805W
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.
Partners with RA Manager, Policy & Intell and RA Manager, Product Registrations to develop and execute effective regulatory implementation strategies to ensure ongoing compliance to changing regulatory requirements. Partners with cross-functional business partners and regional regulatory leaders to develop and execute effective regulatory implementation strategies to deliver product and process changes as planned and prioritized by the business. Manages a small team to execute the above.
• Partnering with RA Manager, Policy & Intell and regional regulatory leaders, interprets changing regulatory requirements and assesses the impact of those changes on the ongoing compliance of product portfolio with local country regulations
• Is responsible for the Standards Management process including monitoring, gap assessment completion and implementation of compliant solutions to new and revised standards, as well as FDA Guidance or EU Regulations as applicable.
• Responsible for assessments of product, process and supplier changes on the status of regulatory licenses globally, including the sourcing and collation of assessments from regional regulatory resources; and partners with cross functional business partners to implement the changes.
• Responsible for completion of Notifications of Change/CE File Amendments (EU) and Letters to File/510(k) submissions (US) to gain regulatory approvals for significant changes.
• Partners with RA Manager, Product Registrations to develop product registration strategies for any required re-registration activities required by changing requirements or product/process changes and provides required technical documentation.
• Gathers and evaluates relevant metrics to monitor KPIs and improve effectivity and efficiency.
• Provides people leadership and mentoring to direct reports, including goal setting, prioritization, coaching, professional development and performance management.
• Provides Regulatory Affairs support during internal and external audits.
• Assists in the development of best practices for Regulatory Affairs processes
• Represents Regulatory Affairs on cross-functional project teams as required
• Independently makes decisions regarding work processes or operational plans and schedules to deliver department and business goals
• Responsible for annual US Medical Device facility registrations and device listings and EU CE File Annual Review processes and activities Ability to understand complex situations and develop strategic plans to meet business needs
- Knowledge of ISO 13485 requirements and technical experience obtained in a R&D setting
- Knowledge of Design Control and change impact assessments
- At least 8 to 10 years’ Regulatory or Quality experience in a medical device, diagnostic or related regulated industry
- Proven knowledge and understanding of US and EU medical device regulations.
- Deep understanding of global regulatory requirements.
- Firsthand experience with EU and US regulatory submissions, and Health Authority interactions.
- Excellent analytical capability, written and verbal communication;
- Independent problem-solving ability essential;
- 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)