Senior Regulatory Affairs Specialist – Vascular (on-site)

About the role

Abbott is seeking a Senior Regulatory Affairs Specialist to join our Abbott Vascular Division in Santa Clara, CA or Temecula, CA. This position offers a supportive and inclusive work environment with competitive benefits and opportunities for professional growth.

Responsibilities

• Provide regulatory input to product lifecycle planning.
• Achieve compliance with product post-marketing approval requirements.
• Maintain annual licenses, registrations, and listings.
• Assist in compliance with product post-marketing approval requirements.
• Support change management process to assess regulatory impact of change and consequent submission requirements.
• Analyze the impact of cumulative product changes to current product submissions.
• Participate in compliance activities by providing regulatory input for non-conforming products, field actions, and CAPA.
• Assist in site audits conducted by internal and external auditing bodies.

Requirements

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience.
• 3-4 years of experience in a regulated industry (e.g., medical products, nutritionals).
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Strong organizational and follow-up skills, as well as attention to detail.
• Organize and track complex information.
• Exercise good and ethical judgment within policy and regulations.
• Use in-depth knowledge of business functions and cross group dependencies/relationships.
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Qualifications

• Bachelor's degree in science/technical discipline (engineering, life sciences).
• Master’s degree.
• Experience with US (510(k), PMA) and EU (Technical Documentation, Change Notification) submissions.
• Experience interacting with US FDA and EU Notified Body.
• Experience reviewing clinical data.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage, manage and/or engage others to accomplish projects.
• Experience working in the Medical Device industry.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.).

Pay

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.