Regulatory Affairs Specialist - Electrophysiology (on-site)

The Opportunity

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  This new team member will support necessary regulatory activities required for product market entry.

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 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 ancies 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 staff.
• May interface directly with 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 regulations and 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

• Bachelor’s Degree or an equivalent combination of education and work experience
• 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, manage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail and focus towards improving quality.
• Multitasks, prioritizes and meets deadlines in timely manner.

Preferred Qualifications

• Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
• Master’s degree
• Experience working in a broader enterprise/cross-division business unit model.
• Experience working in the Medical Device industry.
• Regulatory Affairs Professionals Society Certification is a plus.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is

$50,700.00 – $101,300.00In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Regulatory Operations

DIVISION:EP Electrophysiology

LOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS

WORK SHIFT:Standard

TRAVEL:Yes, 5 % of the Time

MEDICAL SURVEILLANCE:No

SIGNIFICANT WORK ACTIVITIES:Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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