Regulatory Affairs Manager (31018158)
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 113,000 colleagues serve people in more than 160 countries.
The Abbott Electrophysiology (EP) division offers one of the industry’s most comprehensive suite of products, featuring elevated technologies that are designed for effective performance to help provide access, diagnosis and management of arrhythmias. With breakthrough technology and enhanced integration, the Abbott EP solution expands options for each stage in the EP procedural pathway, helping physicians care for their patients
We are seeking an experienced Manager, Regulatory Affairs within Abbott’s Electro-Physiology Business Unit. This position is responsible for planning, creating and implementing solutions for regulatory approvals for our EP products.
WHAT YOU’LL DO:
- Manages the Regulatory Affairs function for a significant business segment.
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
- Develops global regulatory strategies (in conjunction with international regulatory team members) 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.
- Collaborates with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs to support global product development and launch strategies.
- Provides technical guidance and training to RA staff:
- during strategy formulation, submission preparation and development of labeling, marketing or promotional materials and in
- 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.
- Prioritizes work in accordance with business impact
- Establishes regulatory processes where needed
- 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 regulatory submissions and applicable regulations.
- Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).
EDUCATION AND EXPERIENCE YOU’LL BRING:
- Bachelor’s degree in physical/natural sciences, engineering, a related field, or equivalent.
- Minimum of 5+ years of progressively more responsible regulatory submissions experience, including experience with medical devices.
- A demonstrated working knowledge of domestic and international regulations relative to the medical device industry is required.
- A demonstrated ability to analyze and evaluate technologically complex devices is also needed.
- Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, prioritize such tasks, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.
- Must be skilled at delegation, follow-up, and team building as well as a history of being able to multi-task and meet multiple project schedules on time.
- Must be able to work cooperatively and productively with others.
Your preferred qualifications and education:
- An advanced credential in a relevant discipline/concentration.
- Professional certification or designation.
WHAT WE OFFER
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 (Manufacturing Direct Labor 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
Learn more about our benefits that add real value to your life to help you live fully: [Register to View]
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.