Senior Regulatory Affairs Specialist – Vascular (on-site)

Abbott • Santa Clara, CA

9d • $78,000 - $156,000 • Onsite

About The Position

This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of our Santa Clara, or Temecula, CA locations in the Abbott Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions to support continued on-market access of products or new product development. This new team member may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

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). Note: Higher education may compensate for years of experience.
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• 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.

Nice To Haves

• 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 with highly regulated international markets (e.g., China, Canada, Australia, Brazil).
• 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.
• Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner.
• Experience working in the Medical Device industry.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Responsibilities

• Provide regulatory input to product lifecycle planning.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
• Determine and communicate submission and approval requirements.
• Participate in risk-benefit analysis for regulatory compliance.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review and submit regulatory submissions to authorities.
• Monitor impact of changing regulations on submission strategies.
• Monitor applications under regulatory review.
• Monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Maintain annual licenses, registrations, and listings.
• Assist in compliance with product post-marketing approval requirements.
• Assess external communications relative to regulations.
• Assist with labeling development and review for compliance before release.
• 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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

What This Job Offers

• Job Type: Full-time
• Career Level: Senior