Principal Regulatory Affairs Specialist – US New Product Introduction – Diab

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The Opportunity The Principal RA Specialist – US New Product Introduction will work on-site out of our Alameda, CA location in the Diabetes Care Division. Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. Working knowledge of insulin and drug solutions for diabetes management or past experience in submitting NDA / BLA submissions is preferred. The individual has department-level influence with experience in US submissions and on-market changes and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information. What You’ll Work On Develop global regulatory strategies for product development and planning throughout the product lifecycle. Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Provide technical leadership and strategic input on complex issues and to business units. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Create project plans and timelines. Lead functional groups in the development of relevant data to complete a regulatory submission. Write and edit technical documents. Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. Negotiate with regulatory authorities during the development and review process to ensure submission approval. Review and approve labeling to ensure compliance. Monitor emerging issues and identify solutions. Negotiate internally and externally with regulatory agencies. Evaluate regulatory risks of corporate policies. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product post-marketing approval requirements. Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions. Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications. Required Qualifications Bachelor’s Degree in Scientific discipline e.g. Chemistry, Life Sciences, Biology (or equivalent vocational qualifications). Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices. Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications 5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. Experience with either 510(k) applications, PMA supplements, NDA, BLA, US device regulations, US biologics regulations, US drug regulations or with EU and other international medical device regulations and submissions. Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality Systems standards, clinical investigations, ICH guidelines. Experience with word processing, spreadsheet and presentation graphic software packages. Experience working in a broader enterprise/cross-division business unit model. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Ability to identify, solve problems, and work independently with little oversight. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines in a timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel approximately 5%, including international travel.

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