Sr Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair (on-site)

Abbott Laboratories; Santa Clara (CA); On-site; USD 128,000 - 256,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Manager to lead regulatory activities for innovative heart valve solutions. This role involves managing a talented team and ensuring compliance with global regulations while fostering a diverse workplace. The ideal candidate will possess extensive experience in regulatory affairs, particularly in the medical device sector, and will be instrumental in developing strategies for product submissions. Join a forward-thinking company that values employee growth and offers competitive benefits, including health coverage and educational support.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Career development opportunities

Diversity and inclusion initiatives

Qualifications

• 9 years of experience in regulatory affairs and medical devices.
• Strong understanding of FDA and EU regulations for medical devices.

Responsibilities

• Lead and coordinate global Regulatory Affairs activities.
• Manage a team of Regulatory Affairs Specialists and ensure compliance.

Skills

Regulatory Affairs

Quality Management Systems (QMS)

Regulatory Strategy Development

Project Management

Cross-Functional Team Leadership

Problem-Solving Skills

Education

Bachelor’s Degree in a related field

Master’s degree in 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 114,000 colleagues serve people in more than 160 countries.

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.

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

Our location in Santa Clara, CA currently has an on-site opportunity for a Senior Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair. This new team member is responsible for the management and leadership of Regulatory Affairs activities for the Transcatheter Mitral and Tricuspid Heart Valve Repair Franchise. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions and product launches. The Senior Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. The person in this role will manage a team of 3 to 6 Regulatory Affairs Specialists, while also managing day-to-day activities, and interacting with individuals across international locations and time zones, cultures and languages. A portion of time will be dedicated to managerial activities, employee development, strategic oversight and cross-functional alignment to meet regulatory requirements.

What You’ll Work On

• Recruit, coach and develop Regulatory Affairs talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of Regulatory Affairs and organizational objectives.
• Provides direction and guidance to exempt and non-exempt Regulatory Affairs specialists with varied degrees of latitude and independence in their assignments.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change management and leadership.
• Builds strategic cross functional partnerships to further Regulatory Affairs and organizational objectives.
• May develop and execute functional and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules to achieve functional objectives.
• May help develop, monitor and appropriately adjust the annual budget for US and EU Regulatory Affairs submissions.
• Develops regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
• Assesses proposed new or updated regulations and communicates new requirements to the organization.

Required Qualifications

• Bachelor’s Degree in a related field or an equivalent combination of education and experience
• 9 years’ related work experience.
• Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities.
• Understanding of, and ability to interpret and apply, relevant information related to domestic and international regulatory guidelines, policies and regulations.
• Supporting pre-market and post-market cross functional teams; developing and communicating global regulatory strategies for new product submissions or complex changes to on-market products.
• Assessing the regulatory impact of labeling, manufacturing and design changes for PMA approved products, 510(k) products and EU MDR certified products.
• Authoring PMA and/or IDE supplements, Pre-submissions, 510(k)s, EU substantial and non-substantial change notifications.
• Providing direction and monitoring progress of exempt specialists and/or non-exempt staff toward accomplishment of business and Regulatory Affairs goals.
• Mentoring and developing Regulatory Affairs specialists.
• Identifying process improvements and participating in development and execution of improvement activities.
• Working with Regulators and Notified bodies such as FDA and BSI during consultations, initial submissions, deficiency responses and approvals. Working knowledge of regulatory requirements for medical devices in other countries such as Canada, China, Japan, Australia, Brazil, etc.

Preferred Qualifications

• Bachelor’s degree in scientific or engineering related disciplines.
• Master’s degree or additional professional training in regulatory affairs (such as RAC from the Regulatory Affairs Professionals Society.)
• 7 or more years of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and EU Medical Device Regulations for new and on market devices.
• 2 or more years of people management experience.
• Experience working with medical devices for the treatment of heart disease.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
• Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Think analytically with good problem-solving skills.
• Ability to work in a highly matrixed and geographically diverse environment.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $128,000.00 – $256,000.00. In specific locations, the pay range may vary from the range posted.