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Director, Regulatory Affairs, Cardiac

Company: Abbott Laboratories
Location: Lake Forest
Posted on: September 12, 2020

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.

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

WHAT YOU"LL DO:

The Director of Regulatory Affairs, Cardiac leadership role’s main responsibility is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The incumbent has division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally; he/she has an opportunity to influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information; he/she may plan, direct, coordinate and control the regulatory affairs activities related to Abbott Diagnostics products worldwide.

Main responsibilities for the Director of Regulatory Affairs, Cardiac include:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.

Anticipate regulatory and related obstacles and emerging issues throughout the product life-cycle.

Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.

Develop global regulatory strategies and update based upon regulatory changes.

Create and develop product positioning strategies based upon regulatory requirements.

Participate in applicable trade association/industry working groups to influence policy/rule-making in alignment with business strategies.

Negotiate with regulatory authorities during the development and review process to ensure submission approval.

Provide strategic input and technical guidance on regulatory requirements to development teams. Ensure pre=approval compliance activities are completed.

Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation.

Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units.

Creates mid- to long-range plans to carry out objectives established by top management.

Develops and calculates a budget for one or more departments to meet organizational goals.

Forecasts future departmental or group needs including human and material resources and capital expenditures.

Decision Making/Impact:

Assignments are expressed in the form of objectives.

EDUCATION AND EXPERIENCE YOU’LL BRING:

Required

Bachelor’s Degree (+ 16 years) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

MS in a technical area or MBA is preferred; a PhD in technical area or law is helpful but not required

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)

7-10 years of experience in a regulated industry required, for example medical devices, diagnostics, nutritionals; experience in in-vitro diagnostics (IVD) strongly preferred

7-10 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Preferred

Minimum 3 years direct management experience

Extensive experience directing US regulatory strategy

Significant experience interacting and negotiating with the FDA, specifically the Division of Chemistry and Toxicology Devices within OHT7 of CDRH

At Abbott, you can have a good job that can grow into a great career. We offer:

A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)

Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)

Training and career development , with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k) retirement savings with a generous company match

The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Get tailored job recommendations based on your interests. The individual will provide strategic direction and technical guidance on regulatory requirements to a variety of Abbott’s development teams driving premarket strategies that lead to robust submissions...

JOB ID: 30953579

LOCATION United States - Illinois - Lake Forest

DIVISION ADD Diagnostics

TRAVEL Yes, 25 % of the Time

MEDICAL SURVEILLANCE No

SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.

GROWTH PLANNING Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future.

TRAINING & NETWORKS We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.

WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX BEST CORPORATE CITIZENS FORTUNE CHANGE ???????THE WORLD FORTUNE'S MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you about relevant positions, and keep you in mind whenever we have interesting opportunities.

Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans. We provide reasonable accommodation to qualified individuals with disabilities.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

Keywords: Abbott Laboratories, Lake Forest , Director, Regulatory Affairs, Cardiac, Other , Lake Forest, California

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