Senior Regulatory Affairs Specialist - Electrophysiology

The Opportunity

Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, or St.

Paul, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems.

You will provide regulatory guidance to cross-functional partners in support of various programs.

What You’ll Work On

• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.
• Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates.
• Compile, prepare, review and submit medical device submissions to regulatory agencies
• Interfaces directly with FDA and other regulatory agencies.
• Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
• Maintains ongoing surveillance and analysis of all 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.

• Reviews device labeling for compliance with FDA submissions and applicable regulations.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Conducts reviews of product and manufacturing changes for compliance with applicable commercial and clinical regulations.
• 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.

Provides mentoring and leadership to other Regulatory team members

Required Qualifications

• Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development / support;

scientific affairs function.

Preferred Qualifications

• 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industry
• Advanced level degree
• Class II or Class III medical device experience
• Experience with PMA supplements, 510(k) applications, and US device regulations and / or experience with EU and other international medical device regulations and submissions.
• Experience with risk management, design verification, or process validation work.
• Proficient with MS Office suite (Word, Excel, Outlook)
• Previous experience working in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
30+ days ago