Regulatory Affairs Specialist

3 days ago

Pleasanton, California, United States Abbott Laboratories company Full time
About Abbott Laboratories

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Job Summary

We are seeking a Principal Regulatory Affairs Specialist to join our Heart Failure Division on-site in Pleasanton, CA. As an experienced individual contributor, you will provide support for the regulatory department, ensuring efficient and compliant business processes and environment.

Key Responsibilities
  • Develops worldwide strategies for regulatory approval of new and modified products.
  • Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives.
  • Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product.
  • Maintains annual licenses, registrations, and listing information.
  • Assists with compliance to product post-marketing approval requirements.
  • Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
  • Reviews, edits, and approves Advertising and Promotional.
  • Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems.
  • Ensures that details of any new or modified regulations are distributed to appropriate team members.
  • Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
  • Interfaces directly with regulatory agencies as needed.
  • Conducts reviews of product and manufacturing changes for compliance with applicable.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
  • Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications).
  • Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
  • Experience of 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).
  • Minimum of 5 years' experience working with Class II and/or Class III medical devices.
  • Regulatory Affairs Certification (RAC) is a plus.
  • Experience with either 510(k) applications, PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions.
  • Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical.
  • With word processing, spreadsheet and presentation graphic software packages.
  • Experience working in a broader enterprise/cross-division business unit model.
  • 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 and/or engage others to accomplish projects.
  • Ability to identify, solve problems, and work independently with little oversight.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 5%, including international travel.
About Abbott

Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us on LinkedIn and Twitter @AbbottNews and @AbbottGlobal.

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