Sr. Records Specialist

Helping Hearts Heal Themselves

AGA Medical Corporation specializes in the development and manufacturing of innovative medical devices for use in cardiovascular applications. AGA's patented AMPLATZER family of occlusion devices offers new and enhanced solutions for transcatheter treatment of complex congenital heart defects. We are a fast-growing, innovative company, looking for creative professionals to join our team.

As a Senior Records Specialist, you will be responsible for leading and supervising records management operations and is responsible for tracking and safeguarding all AGA Medical Corporation physical records.
REQUIREMENTS
Bachelor’s degree or a minimum of seven years experience managing records and/or documents in a medical device, pharmaceutical or biopharmaceutical manufacturing facility.
Certified Records Manager (CRM) certification preferred.
Three to five years physical records management experience in an FDA-regulated environment; medical device experience preferred.
Three to five years experience with electronic document management systems and document scanning systems preferred.
Experience leading the creation and implementation of records management processes and procedures in an FDA-regulated environment.
Successful leadership of project teams.
In-depth knowledge of current records management best practices.
Understanding of 21 CFR 820 Quality System Regulation and 21 CFR Part 11 Electronic Records and Signatures.
Ability to propose and implement innovative records management solutions.
Space/capacity planning skills (working in conjunction with the Facilities Manager).
Ability to create or update third party off-site storage and retrieval processes.
Exceptional attention to detail.
Ability to lead teams for short and long-term projects to deliver quality results, often in short timeframes.
Enjoy working in a fast-paced environment.
Self-starter—ability to identify areas in need of improvements and propose solutions.
Must be able to perform standard duties and special projects with minimal supervision.
Good written and verbal communication, record keeping and problem solving skills.
Computer proficiency with Microsoft applications.
Ability to work independently and take initiative.

For a more detailed job description, please visit our website at www.amplatzer.com.

We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.

An Equal Opportunity / Affirmative Action Employer

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