Regulatory Affairs Specialist II

Regulatory Operations Specialist I

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
• An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - An affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Structural Heart Business Mission: Why We Exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

We are seeking a Regulatory Operations Specialist I for our St. Paul, MN Structural Heart team to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities.

What You'll Work On

• Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• 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, if requested.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• May interface directly with FDA and other regulatory agencies if so directed.
• 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) regulations, international regulations and 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.

Required Qualifications

• Bachelors Degree ( 16 years) Technical discipline preferred or an equivalent combination of education and work experience.
• Some experience with medical device industry preferred.
• 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.

Preferred Qualifications

• Bachelor's degree in a technical discipline.
• 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.

The base pay for this position is $60,000.00 $120,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations

DIVISION: SH Structural Heart

LOCATION: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.