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Job Details

Associate Regulatory Affairs Specialist

Company name
Integer

Location
Chaska, MN

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Associate Regulatory Affairs Specialist

Integer

Chaska

MN

Job #683104499

At Integer, our vision and values are embedded in everything we do!

If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!

Adheres to GB Core Beliefs and all safety and quality requirements.

Responsible for international submissions and acts as the primary contact to Regulatory agencies. May provide team support with other submissions. Consults with multiple sources for information in order to prepare submissions.

Reviews Engineering Change Orders that requires regulatory review and approval to ensure compliance with national and international government regulations.

Develops submission strategies for, and prepares international product registrations.

Assists in planning and managing the process for submission compilation to support simultaneous and changing project deadlines.

Monitors and maintains U.S. submission, Foreign Government Support files, Non-file decisions, and Product files consistent with current department practices.

May participate on Product Development teams, providing input in regulatory, timelines and direction.

Compiles, prepares, audits, and distributes reports for submission related documents and special reports.

Partners with IT to identify emerging software applications and technological advancements relating to department needs.

Identifies and coordinates Regulatory department training opportunities. Tracks and communicates changes in medical device industry standards, regulations, and guidance documents to Regulatory department regularly.

Assists in the development of Regulatory Database for Regulatory Questions and Responses.

Manages the Regulatory Affairs Intranet site including maintenance and enhancements. Maintains data and approval tracking.

Conducts research, compiles and summarizes data for Post-market Surveillance including MAUDE, Recall, and Complaints.

Prepares, maintains, and audits annual FDA Device Listings for multiple Facilities.

Obtains and Legalize/Authenticate/Apostille US CFGs and other Regulatory Documents.

Compiles, organize, track documentation required for Notified Body and other audits.

Works on special projects as requested in or outside

Performs other functions as required.

Minimum Education:

Associate’s degree required. Bachelor’s degree in a related field preferred. Equivalent combination of education and experience may be considered.

Minimum Experience:

Minimum 5 years of experience in organizing and accurately controlling large amounts of detailed information via electronic systems. Regulatory experience preferred but not required.

Specialized Knowledge:

Ability to research, compile, summarize, and present information / basic statistical calculations from various sources, such as, medical device regulations, standards, and professional journals. Prior regulatory experience/exposure, experience with Internet/Intranet technology, and interactive software applications.

Special Skills:

Ability to work in a team environment. Highly organized and able to work on and track multiple projects simultaneously. Strong communication skills; Intermediate to advanced Microsoft Office skills including PowerPoint, Visio, and Project.

Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at ~~~ .

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy, gender, and gender nonconformity), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at

Updated 06/12/2018

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Integer

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