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Abbott

Makes heart devices, glucose sensors and lab tests

Regulatory Affairs Specialist 2 - Structural Heart

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSanta Clara, CA, USA$81.5k - $141.3k

About the Job

Requirements

  • A bachelor's degree or an equivalent combination of education and work experience is required.
  • At least 3 years of related experience, including at least 2 years of regulatory experience, is required.
  • Experience with either 510(k) applications, IDE supplements, PMA supplements, and U.S. device regulations, or with EU and other international medical device regulations and submissions, is required.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment, and to leverage, manage, or engage others to accomplish projects, is required.
  • Strong problem-solving skills and the ability to think strategically and see the big picture are required.
  • Adaptability and the ability to switch priorities and accomplish all tasks are required.
  • Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels, are required.
  • Strong organizational and follow-up skills, along with attention to detail, are required.
  • Ability to multitask, prioritize, and meet deadlines in a timely manner is required.

Responsibilities

  • Prepare regulatory applications for the FDA or international regulatory agencies to meet departmental and organizational objectives.
  • Create, review, and approve engineering changes.
  • Review and provide input on device labeling.
  • Serve as a core team member by reviewing and analyzing applicable regulatory guidelines and project regulatory assessments as needed.
  • Review and evaluate communications to ensure they convey necessary detail and comply with applicable regulatory standards, including those set by the FDA or other worldwide regulatory agencies, for international affiliates.
  • Maintain domestic and international medical device regulations and keep worldwide submission requirements current in regulatory submission databases and file systems; distribute information about new or modified regulations and requirements to appropriate personnel.
  • Interface directly with the FDA and other regulatory agencies as needed.
  • Support product release by creating GTS licenses or reviewing and approving product-release requests.
  • Review protocols and reports to support regulatory submissions.
  • Support business-segment initiatives identified by divisional management and support Quality Management Systems, Environmental Management Systems, and other regulatory requirements.
  • Comply with U.S. FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communication and collaboration with employees at all levels, customers, contractors, and vendors.

Desired Qualifications

  • A bachelor's degree in a science or technical discipline, such as engineering, life sciences, or mathematics, is preferred.
  • A master's degree is preferred.
  • Experience with regulatory activities required for clinical trials is preferred.
  • Experience working in a broader enterprise or cross-division business-unit model is preferred.
  • Experience working in the medical device industry is preferred.
  • Regulatory Affairs Professionals Society certification is a plus.

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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