Principal Regulatory Affairs Specialist (Business Partnerships).

Abbott•Alameda, CA

29d•$98,000 - $196,000•Onsite

About The Position

Principal Regulatory Affairs Specialist (Business Partnerships). Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: · Career development with an international company where you can grow the career you dream of. · Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. · An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. · A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. · A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. 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 –Business Partnerships will work on-site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health 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. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes. This is an exciting opportunity with responsibilitiesrelated to new strategic business initiatives globally , which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs. Projects will focus on driving the regulatory strategy for business partnership initiatives involving Cloud/ Sensor based external partnerships .. The individual has department level influence with experience in global regulatory 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 compliance strategy, and provide executive management with regulatory metrics/information.

Requirements

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).

Nice To Haves

5 years’ experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.
Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international medical device regulations and submissions.
Familiar with relevant regulatory requirements for medical devices 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.

Responsibilities

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.
Support 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.
Review and approve labeling to ensure compliance.
Monitor emerging issues and identify solutions.
Negotiate internally and externally as regulatory liaison
Evaluate regulatory risks of corporate policies.
Oversee processes & improvements involved with Partnership regulatory activities
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.
Provide regulatory input for product recalls and recall communications.

Benefits

Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

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