Strategic Regulatory Affairs Manager - Vascular

Thornton Tomasetti; San Jose (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement plan with high-em

Tuition reimbursement and educationBEN

Job summary

Abbott in Santa Clara, CA is seeking a Regulatory Affairs Manager to combine scientific, regulatory, and business expertise to enable compliant products. The role involves leading regulatory strategy, developing submissions for FDA and international agencies, and guiding cross-functional teams to meet deadlines.

The candidate will work onsite in Santa Clara, CA with responsibilities spanning pre- and post-approval activities and mentoring junior staff within Regulatory Operations.

Qualifications

• Bachelor's Degree in a related field or equivalent education/experience.
• Minimum 4 years’ experience in a regulated industry; 2–5 years in regulatory preferred.
• Ability to communicate effectively with diverse audiences, verbally and in writing.
• Familiarity with domestic and international regulatory guidelines and submissions.

Responsibilities

• Develop regulatory policies, processes and SOPs and train key staff.
• Provide regulatory input to product lifecycle planning and strategy.
• Prepare robust regulatory applications (FDA and international) for submission.
• Lead cross-functional regulatory strategy and manage deadlines and projects.

Skills

Regulatory affairs

Written & verbal communication

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's Degree or equivalent

Job description

Abbott in Santa Clara, CA is seeking a Regulatory Affairs Manager to combine scientific, regulatory, and business expertise to enable compliant products. The role involves leading regulatory strategy, developing submissions for FDA and international agencies, and guiding cross-functional teams to meet deadlines.

The candidate will work onsite in Santa Clara, CA with responsibilities spanning pre- and post-approval activities and mentoring junior staff within Regulatory Operations.