Regulatory Affairs Project Manager - Abbott Laboratories : Job Details

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 medicines. We employ over 114,000 colleagues serving more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do meaningful work, grow, learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development opportunities within an international company.

• Free medical coverage for employees via the Health Investment Plan (HIP) PPO.

• Retirement savings plans with high employer contributions, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefits.

• Recognition as a great place to work globally, including awards for diversity, working mothers, female executives, and scientists.

• Our Cardiac Rhythm Management Business aims to restore health and improve quality of life through innovative device solutions.

The Opportunity –

We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rhythm Management team in Sylmar, CA. This individual will leverage scientific, regulatory, and business knowledge to ensure products meet legislation requirements, influence at department/group/site levels, and support product registration worldwide.

Key Responsibilities include:

Strategic Planning:

• Develop and train personnel on regulatory policies, processes, and SOPs.

• Evaluate regulatory risks and provide input on product lifecycle planning.

• Monitor regulatory outcomes and assist in developing multicountry strategies.

• Conduct regulatory due diligence for acquisitions and propose strategies on complex issues.

• Identify data needs, obtain data, and ensure effective presentation for product registration.

Pre-market Activities:

• Assess documentation acceptability, prepare submissions, and monitor application reviews.

• Communicate submission progress and respond to regulatory inquiries.

• Evaluate changes for regulatory impact and negotiate with authorities.

Postmarket Activities:

• Manage licenses, registrations, and ensure compliance with postmarketing requirements.

• Review advertising and promotional materials for compliance.

• Develop SOPs and systems for tracking product events.

Job-specific responsibilities may include:

• Medical writing, labeling, regulatory reporting (e.g., REACH), standards, import/export, and country-specific support.

Qualifications include:

• Bachelor's degree in science, engineering, or related fields; advanced degrees or certifications like RAC are a plus.

• Minimum 4 years of experience in a regulated industry, with 2-5 years in regulatory affairs preferred.

Required knowledge includes:

• Regulatory guidelines, agency processes, product laws, and international trade requirements.

Skills include:

• Effective communication, technical writing, project management, analytical thinking, and judgment.

• Preferred qualifications include experience with Windchill, SOP writing, and 510(k)/PMA submissions.

The base pay range is $112,000.00 – $224,000.00, with variations depending on location.