Job Details

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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Job Description

Working at Abbott

At Abbott, you can do work that matters, grow and learn, care for yourself and your 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 your career.
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
• An excellent retirement savings plan with high employer contributions.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
• A company recognized as a great place to work globally and for diversity, working mothers, female executives, and scientists.

Our Business Purpose

To restore health and improve quality of life through the design and provision of device and Cardiac Rhythm Management solutions.

The Opportunity

We are seeking a Regulatory Affairs Project Manager for our Cardiac Rhythm Management team in Sylmar, CA. The role involves ensuring products meet regulatory requirements, sharing knowledge within the team, and managing data for product registration worldwide.

Responsibilities include:

Strategic Planning

• Developing regulatory policies and SOPs, training personnel.
• Evaluating regulatory risks, providing input to product lifecycle planning.
• Monitoring regulatory outcomes, assisting in multicountry strategies, and regulatory due diligence.
• Proposing strategies on complex issues, determining submission requirements, and identifying emerging issues.

Premarket Activities

• Assessing documentation, preparing and submitting regulatory filings, monitoring application reviews.
• Communicating progress, evaluating changes, negotiating with authorities, and providing strategic guidance.

Postmarket Activities

• Maintaining licenses, ensuring compliance, reviewing advertising, and managing product events.

Additional Responsibilities

• Medical writing, labeling, restricted substances reporting, import/export, and country-specific support.

Leadership & Planning

• Developing goals, leading projects, mentoring staff, and exercising independent judgment.

Qualifications

• Bachelor's degree in science, engineering, or related field; MS or PhD preferred. Certification (e.g., RAC) is a plus.
• Minimum 4 years in a regulated industry, with 2-5 years in regulatory roles preferred.

Skills & Knowledge

• Regulatory guidelines, agency processes, legal requirements, and international trade regulations.
• Effective communication, project management, analytical thinking, and regulatory strategy development skills.

Preferred Qualifications

• Experience with PLM software, SOP writing, and submissions like 510k and PMA.

The salary range is $112,000 to $224,000, depending on location and experience.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Project Management and IT