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Regulatory Specialist III

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

A Day in the Life

  • Coordinates, compiles, and submits U.S, and/ or International regulatory submissions, including filing and/or creation of Technical files and 510ks.
  • Prepares robust regulatory applications to achieve departmental and organizational objectives.
  • Represents RA on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.
  • 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 and marketing materials for compliance with FDA submissions and applicable regulations.
  • Assist with internal/external audits and Establishment registrations/Renewals.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Creates, reviews and approves engineering change orders.
  • Reviews protocols and reports to support regulatory submissions.
  • Communicates with and maintain productive, constructive relationships with external customers as required - US FDA, Health Canada, regulatory representatives, and notified-bodies.
  • Review and approve CAPAs, SCARs and CCARs as necessary.
  • Support activities related to trending within QMS from a Regulatory perspective.
  • Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

What your background should look like:

  • This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR).  Applicants must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.
  • Familiar with formal quality system assessments (i.e. ISO 9001, ISO13485:2016/MDSAP).
  • Must be able to read and follow all written and implied directions, policies and procedures.
  • Ability to analyze and resolve problems using various failure analysis techniques to isolate failures down to the root cause.
  • Good organization, verbal, writing and listening skills.
  • High level of attention to detail and accuracy.
  • Work independently in a team environment.
  • Must be proficient with Microsoft Office applications (Word, Excel, PPT, etc.).

 

  • 2-year degree preferred.
  • 2-4 years’ experience in Medical device Industry in Regulatory/Quality role.
  • This individual must be self-driven, results-oriented with a positive outlook and a clear focus on quality.
  • Comfortable in dealing with employees at all levels. Good communicator and customer friendly.
  • Must be proficient in use of MS Office Excel, Word, Access, and PowerPoint.
  • Good communication and computer skills, including data analysis and report writing skills.

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity

TE Connectivity is a $13 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedInFacebookWeChat and Twitter.

 

What TE Connectivity offers:

We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.

  • Competitive Salary Package
  • Performance-Based Bonus Plans
  • Health and Wellness Incentives
  • Employee Stock Purchase Program
  • Community Outreach Programs / Charity Events
  • Employee Resource Groups

Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.

Location: 

ANDOVER, MN, US, 55304

City:  ANDOVER
State:  MN
Country/Region:  US
Travel:  None
Requisition ID:  69692
Alternative Locations: 
Function:  Quality


Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Engineer, Law, Quality Manager, Developer, Legal, Engineering, Quality, Technology

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