Regulatory Affairs Specialist II - Medical Devices (Global)

Regulatory Jobs; Temecula (CA); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott, a global healthcare leader, seeks a Regulatory Affairs Specialist II for its Vascular Division in Temecula, CA. You will drive regulatory strategy and submissions across EU/US markets, ensuring compliance throughout product lifecycles for minimally invasive vascular devices.

Ideal candidates have 2–3 years in regulated industries, strong communication skills, and a solid grasp of global medical device regulations including ISO 13485 and ISO 14971. Equal Opportunity Employer.

Qualifications

• Bachelor’s degree (or equivalent)
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, R&D/support, scientific affairs, operations, or related area.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Responsibilities

• Evaluate regulatory impact and develop global regulatory strategies to support product lifecycle management activities.
• Prepare and support regulatory submissions for Vascular devices to achieve departmental and organizational objectives.
• Assess proposed product, manufacturing, supplier, process, and labeling changes to determine regulatory impact and submission requirements across global markets.
• Develop and document regulatory assessments supporting design control and change management activities.
• Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation.

Skills

Strong verbal and written comms

Team collaboration

Regulatory knowledge

Project management

Education

Bachelor’s degree (or equivalent)

Bachelor’s degree in science (biology, chemistry, microbiology, etc.)

Master’s degree in Regulatory Affairs

Certification (RAC)

Job description

Abbott, a global healthcare leader, seeks a Regulatory Affairs Specialist II for its Vascular Division in Temecula, CA. You will drive regulatory strategy and submissions across EU/US markets, ensuring compliance throughout product lifecycles for minimally invasive vascular devices.

Ideal candidates have 2–3 years in regulated industries, strong communication skills, and a solid grasp of global medical device regulations including ISO 13485 and ISO 14971. Equal Opportunity Employer.