Senior Regulatory Affairs Specialist

2 weeks ago

Alameda, California, United States Abbott Laboratories company Full time


Position Title: Regulatory Operations Specialist III – Digital Health Technologies

Company Overview: Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey.

Our extensive portfolio encompasses innovative technologies across various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medicines. With a workforce of 114,000 professionals, we serve communities in over 160 countries.



Role Overview:
As a Regulatory Operations Specialist III, you will be an integral part of our team located in the Diabetes Care Division. Your primary focus will be on supporting the regulatory department to ensure seamless and compliant operational processes.

Key Responsibilities:

  • Support the regulatory department to maintain efficient and compliant business practices.
  • Collaborate across various business functions to execute tasks and provide consultative insights.
  • Identify necessary data, acquire it, and ensure effective presentation for the global registration of digital products.
  • Prepare and oversee documentation required for worldwide registration.
  • Contribute regulatory insights to the planning of digital product lifecycles.
  • Review regulatory outcomes against initial product concepts to guide future actions.
  • Assist in developing regional regulatory strategies and adapt them based on regulatory changes.
  • Investigate and evaluate the regulatory history of classes and contexts to assess implications for product approval.
  • Anticipate regulatory challenges by identifying trade issues.
  • Communicate submission and approval requirements effectively.
  • Participate in risk-benefit analyses to ensure regulatory compliance.
  • Assess the quality and acceptability of preclinical and clinical documentation for submissions.
  • Compile, prepare, and review regulatory submissions to relevant authorities.
  • Monitor the impact of evolving regulations on submission strategies.
  • Track applications under regulatory review and submit necessary reports to authorities.
  • Evaluate proposed changes in preclinical, clinical, and manufacturing processes for regulatory strategies.
  • Engage with regulatory stakeholders to facilitate submission approvals.
  • Ensure compliance with post-marketing product requirements.
  • Review external communications in relation to regulations.
  • Assist in label development and compliance review prior to product release.
  • Analyze cumulative product changes and their implications for current submissions.
  • Contribute to crisis and issue management programs.
  • Ensure timely reporting of product safety issues to regulatory agencies.
  • Provide regulatory input for product recalls and associated communications.

Qualifications:

  • Bachelor's Degree or equivalent combination of education and experience.
  • Minimum of 5 years of relevant work experience.
  • Preferred: Bachelor's degree in a technical field such as biology, chemistry, or engineering.
  • Advanced degree in Engineering, Sciences, or related discipline is advantageous.
  • 5+ years of experience in the Medical Device industry.
  • 1-2 years of regulatory experience.
  • Strong communication skills, both verbal and written, with the ability to negotiate effectively.
  • Analytical thinking and problem-solving capabilities.
  • Experience with 510(k), PMA, or other international regulatory submissions.
  • RAPS Certification is a plus.

At Abbott, you will have the opportunity to engage in meaningful work, pursue personal and professional growth, and contribute to a diverse and inclusive workplace.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce.

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