DVP Regulatory Affairs

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Abbott: Making An Everlasting Impact on Human Health for 125 Years

Abbott is a global health care company devoted to improving life through the development of products and technologies that span the breadth of health care. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 99,000 people. In 2018, the company's sales exceeded US$30.6 billion.

Abbott Point of Care: Poised for Growth

Abbott Point of Care (APOC), a $600 million division of Abbott (NYSE: ABT), enables health care professionals to accurately achieve real-time, lab-quality diagnostic results at the point of care within minutes. Testing at the point of care enables health care professionals to make rapid triage and treatment decisions when diagnosing a patient's condition or monitoring a treatment response. By simplifying the testing process, clinicians can focus on what matters most—caring for the patient.

Abbott Point of Care's i-STAT Analyzer is a handheld system that is used with single-use i-STAT test cartridges. Together they form the i-STAT System*—a blood analysis system that provides health care professionals with the information they need to rapidly make treatment decisions. Patient-side testing with the i-STAT System is as easy as inserting 2 or 3 drops of blood into the cartridge, inserting the cartridge into the handheld, and then viewing test results in as little as 2 minutes for most cartridges. Test results are uploaded automatically—delivered wirelessly with the i-STAT Wireless or directly when the i-STAT handheld is placed in a downloader. The i-STAT System eliminates process steps and handoffs to help reduce the incidence of errors and promote patient safety.

Hospitals and clinics in more than 100 countries around the world depend on the i-STAT System in critical care situations. For more information about Abbott Point of Care and the i-STAT System, please visit https://www.pointofcare.abbott.

DVP, Global Regulatory Affairs: A Unique Leadership Opportunity

As the DVP, Global Regulatory Affairs, you will lead our Global Regulatory Affairs Team and serve as a key member of the APOC Leadership Team. You will contribute to APOC's vision and mission by defining a strategy and roadmap to ensure regulatory preparedness and compliance to enable new product launches and on-market product availability. You will be responsible for leading all submissions and communications with regulatory authorities and managing international product registrations. In your new role, you will report to the President, Abbott Point of Care.

We're looking for an entrepreneurial leader who is passionate about redefining health care through collaboration, innovation, and unconventional thinking. It's a mission that takes some serious smarts, intense curiosity and determination to be the best. Come be part of a winning team that's changing how health care is delivered!

• Have Fun—come join a business that has a strong R&D pipeline and is poised for explosive, double-digit growth over the next several years!
• Be An Entrepreneur, Build a Business—put your entrepreneurial skills to work and build a business with the support of a stable multinational health care corporation
• High Visibility—the launch of APOC new products is highly visible at the top levels of the Corporation
• Company Culture— a collegial culture focused on helping health care professionals and patients
• Small Company Feel, Large Company Stability—gain the benefits of working in a successful, entrepreneurial Division within a large, stable and growing multi-national health care company
• Attractive Compensation and Benefits—a highly attractive compensation package featuring strong bonus and long-term incentive plans
• Career Development—the successful candidate will receive career development opportunities leading to general management

Responsibilities:

• Leads team to develop and implement the global regulatory strategy for Abbott's Point of Care portfolio
• Leads the preparation and review submissions to the FDA and other global regulatory bodies
• Leads the preparation and maintenance of the product's Technical File and registration status globally
• Represents Regulatory Affairs for Point of Care globally. In this capacity, acts as single point of contact for the business on regulatory issues for all on market and new product introductions.
• Works closely with members of the leadership team (commercial, R&D, operations, Quality), to successfully launch products to the US and international markets.
• Provides regulatory guidance to cross-functional groups including Global Strategic Marketing, R&D, Manufacturing, quality, and commercial
• Directs efforts for planning and execution of required regulatory filings
• Accountable for ensuring that all regulatory reviews are conducted in a timely manner ahead of key governance meetings and major (issue driven) ad hoc reviews by Sr. Management.
• Works with the labeling and regional groups to ensure appropriate labeling/translation content
• Attracts, develops, and retains a high performing regulatory organization while developing a strong talent and leadership pipeline capable of delivering regulatory success in changing market environments.

Qualifications / Experience:

Experience

• 10+ years regulatory experience within medical device industry, IVD experience is highly preferred
• In depth experience leading regulatory strategy and execution of new product launches in US and international markets.
• Proven ability to successfully plan for and manage new regulatory submissions while overseeing the routine daily maintenance of existing regulatory applications
• Deep experience ensuring compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, and other International Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control.
• Must have experience presenting to US FDA.
• Must be skilled in relationship building and matrix management, demonstrating superior leadership and coaching skills.
• Must have experience participating in multiple regulatory submissions and in advising clinical project teams toward successful product approvals or label extensions. Must have knowledge of clinical trial methodology and the broader functions associated with clinical trial conduct.
• Adept at clearly defining objectives and priorities, establishing appropriate milestones, and leading cross-functional teams to meet and exceed goals, even under adverse circumstances
• Comfort with ambiguity; demonstrated ability to take ownership of problems, exercise sound judgment and independently determine appropriate course of action where precedent may not exist
• Skilled at influencing outcomes by catalyzing and shaping dialogue across and outside the organization, demonstrating competence and confidence, being accessible, being a good listener, and using fact-based persuasion, passion, and persistence as appropriate to the audience and issue at stake
• An approachable and credible communication style, both verbal and written, to keep all levels of the organization informed, engaged and motivated
• Unquestionable ethics and integrity

Qualifications

• Bachelor of Science in biologic or medical science; MS degree is preferred
• Written and verbal fluence in English is required

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