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Manager, Regulatory Affairs

Company: Abbott Laboratories
Location: Plano
Posted on: September 17, 2020

Job Description:

Regulatory Affairs United States - Texas - Plano

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.

Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson’s disease and essential tremor symptoms, steering away from side effects.

Our location in Plano, TX, currently has an opportunity for a Manager, Regulatory Affairs. This position manages the Regulatory Affairs function for the Neuromodulation Business. It is responsible for planning, creating and implementing solutions for regulatory approvals of products.

WHAT YOU’LL DO

Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.

Develops global regulatory strategies for new and modified medical devices.

Provides Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.

Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.

Provides technical guidance and training to RA staff: o during strategy formulation, submission preparation and development of labeling, marketing or promotional materials and in o training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.

Prepares submissions for new devices and device or manufacturing changes.

Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).

Reviews protocols and reports to support regulatory compliance and submissions.

Reviews device labeling and advertising materials for compliance with FDA submissions and applicable regulations.

Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Performs other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

Bachelor’s degree (BS, BA) (technical discipline preferred) with at least 8 years’ technical experience.

Minimum six years’ medical device regulatory experience.

Experience working in a broader enterprise/cross-division business unit model preferred

Extensive experience with US and global medical device regulations and submissions.

Preferred

Experience working in a broader enterprise/cross division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Ability to work effectively within a team in a fast-paced changing environment.

Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Ability to travel approximately 15%, including internationally.

WHAT WE OFFER

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

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. JOB ID: 30959113

LOCATION United States - Texas - Plano

ADDITIONAL LOCATION United States - Texas - Austin

DIVISION NM Neuromodulation

TRAVEL Yes, 10 % of the Time

MEDICAL SURVEILLANCE No

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

Keyboard use (greater or equal to 50% of the workday)

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, Plano , Manager, Regulatory Affairs, Other , Plano, Texas

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