Loading...
 
Share this Job
Apply now »

Sr. Regulatory Specialist


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

  • Manages the Regulatory Affairs function
  • Develops global regulatory strategies
  • Ensure compliance to 21 CFR 820, ISO 13485, MDD, MDSAP, 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 Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.
  • Acts as a liaison with Quality, R&D, Legal, and Operations.
  • Provides regulatory guidance
  • Responsible for submission preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.
  • Prepares submissions for device design changes and /or manufacturing changes.
  • Reviews product and manufacturing changes for compliance with applicable regulations
  • Reviews protocols and reports to support regulatory compliance and submissions.
  • Reviews device labeling and advertising materials for compliance with applicable regulations.
  • Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).
  • Review and develop risk management plans.
  • Uses project management experience to create timelines and provide deliverables for regulatory projects.
  • Provides guidance to management on upcoming regulatory changes and the impact of those changes.

What your background should look like:

  • Bachelor’s degree (BS, BA) (technical discipline preferred)
  • At least 3- 5 years' Regulatory experience.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Ability to travel approximately 10%, including international

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity
TE Connectivity is a 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 approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

 

What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Generous 401(k) Plan
  • Tuition Reimbursement
  • Benefits start on day one
  • Charity Donation Matching Program
  • Competitive Paid Time Off
  • Employee Resource Groups
  • Employee Stock Purchase Program
  • Healthcare for Associates and Families
  • Health and Wellness Incentives
  • Life Insurance and Disability Protection

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.

 

EOE, Including Disability/Vets

Location: 

Andover, MN, US, 55304

City:  Andover
State:  MN
Country/Region:  US
Travel:  10% to 25%
Requisition ID:  79193
Alternative Locations: 
Function:  Legal


Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Engineer, Law, Developer, Risk Management, Legal, Engineering, Technology, Finance

Apply now »