Regulatory Affairs Manager — Global Strategy & Compliance

Abbott; Santa Clara (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

Excellent retirement savings plan

Job summary

Abbott in Santa Clara, CA is seeking a Regulatory Affairs Manager to combine science, regulatory insight, and business acumen to enable products from development to market. This onsite role offers mentorship, cross‑functional leadership, and opportunities to influence regulatory strategy across multiple regions.

The position requires a strong background in regulatory affairs, experience with global submissions, and the ability to lead teams while ensuring compliance and timely approvals.

Qualifications

• 4 years in a regulated industry (medical products, nutritionals)
• Strong written and verbal communication with diverse audiences
• Knowledge of domestic and international regulatory guidelines and submissions
• Ability to lead cross‑functional teams for regulatory submissions
• Experience with US and international regulatory submissions (PMA, 510(k), CE)

Responsibilities

• Develop regulatory policies, processes and SOPs and train staff
• Provide regulatory input to product lifecycle planning and strategy
• Prepare robust regulatory applications to FDA and international agencies
• Develop multi-country regulatory strategies and update plans
• Support pre/post-approval clinical strategy and submissions
• Anticipate regulatory obstacles and propose solutions
• Interface with management and regulatory authorities to ensure approvals
• Mentor junior staff and lead cross-functional projects

Skills

Regulatory knowledge

Regulatory submissions

Communication

Leadership

Cross-functional teamwork

Education

Bachelor's degree in related field

Master’s or Ph.D. in technical area

RAC certification (preferred)

Job description

Abbott in Santa Clara, CA is seeking a Regulatory Affairs Manager to combine science, regulatory insight, and business acumen to enable products from development to market. This onsite role offers mentorship, cross‑functional leadership, and opportunities to influence regulatory strategy across multiple regions.

The position requires a strong background in regulatory affairs, experience with global submissions, and the ability to lead teams while ensuring compliance and timely approvals.