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. Our 114,000 colleagues serve people in more than 160 countries.

REQUIRED QUALIFICATIONS

• Bachelors Degree (± 16 years), Technical discipline preferred

• Minimum 3 years, Related experience, including a minimum of two years regulatory experience

• Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
• Experience working in a broader enterprise/cross-division business unit model preferred. 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. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 5%, including internationally.

PREFERRED QUALIFICATIONS

• Medical Device industry experience.
• Experience working in a broader enterprise/cross-division business unit model.
• Strong problem-solving skills and ability to think strategically and see the big picture.
• Adaptable with the ability to switch priorities and accomplish all tasks.
• Process oriented.
• Preferred 510k experience
• Preferred Class II or Class III device experience
  The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted

• Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Reviews and provides input on device labeling.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with FDA and other regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Reviews protocols and reports to support regulatory submissions.
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.