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Abbott

Makes heart devices, glucose sensors and lab tests

Principal International Regulatory Operations Specialist - Diabetes Care

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeAlameda, CA, USA$100k - $200k

About the Job

Requirements

  • A bachelor's degree in a scientific discipline, such as chemistry, life sciences, or biology, or equivalent vocational qualifications.
  • Experience in regulatory submissions for pharmaceutical, in vitro diagnostic device, and/or medical device products.
  • Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).

Responsibilities

  • Contribute regulatory input to product and process change plans triggered by new or revised regulations or standards, and ensure affected dossiers, technical documentation, labeling, and procedures are updated on time.
  • Coordinate with regional Regulatory Affairs teams to update submission strategies and registration maintenance in response to regulatory changes.
  • Establish and maintain a structured horizon-scanning log for priority jurisdictions, and publish concise impact assessments with an owner, due date, and evidence links.
  • Lead or co-lead cross-functional working sessions to document decisions, actions, and closure evidence, and track progress against external compliance dates.
  • Assist in developing and reviewing standard operating procedures.
  • Provide regulatory input to product lifecycle planning.
  • Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Assist in developing regional regulatory strategy and update the strategy based on regulatory changes.
  • Understand, investigate, and evaluate regulatory history and background of the product class and disease, therapeutic, or diagnostic context to assess regulatory implications for approval.
  • Determine market access issues to anticipate regulatory obstacles.
  • Determine and communicate submission and approval requirements.
  • Participate in risk-benefit analysis for regulatory compliance.
  • Assess the acceptability of documentation and deliver clear gap assessments with closure plans and evidence.
  • Monitor the impact of changing regulations on submission strategies.
  • Maintain annual licenses, registrations, and listings as applicable.
  • Assist with compliance with product post-marketing approval requirements.
  • Assess external communications relative to regulations.
  • Review regulatory aspects of contracts.
  • Assist with label development and review labels for compliance before release.
  • Contribute to development and operation of the crisis and issue management program.
  • Provide regulatory input for product recalls and recall communications.
  • Support knowledge sharing by facilitating training and providing guidance to peers on new or updated requirements.
  • Provide subject-matter expertise and hands-on execution for the regulatory department to ensure efficient and compliant business processes and environment.
  • Identify emerging regulations, interpret their impact, aid in developing gap assessments, and coordinate assigned actions through closure with owners.
  • Ensure emerging regulatory items are effectively presented to stakeholders across the organization.
  • Prepare and submit documentation needed for registration worldwide or oversee its preparation.

Desired Qualifications

  • A bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology), mathematics, engineering, or a medical field.
  • Certification such as RAC from the Regulatory Affairs Professionals Society.
  • Two to three years of regulatory experience; experience in quality assurance, research and development/support, engineering, scientific affairs, operations, or a related area may also be considered.
  • Experience collaborating across quality assurance, research and development, clinical, labeling, and operations; strong cross-functional experience with demonstrable regulatory change leadership may also be considered.
  • An advanced-level degree.
  • Experience with European Union and other international medical device, drug, or pharmaceutical regulations and submissions.
  • Experience with design controls in medical device, IVDR, and pharmaceutical industries.
  • Proficiency with Excel and PowerPoint and experience presenting information to leadership; experience with Veeva Vault and dashboarding or automation such as reminders and escalations is a plus.
  • Previous experience working in a highly matrixed and geographically diverse business environment.
  • Strong verbal and written communication skills and the ability to communicate effectively at multiple organizational levels.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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