Senior Regulatory Specialist at TE Connectivity
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Andover, Minnesota
TE Connectivity (NYSE: TEL) is a $12 billion global technology leader. Our connectivity and sensor solutions are essential in today's increasingly connected world. We collaborate with engineers to transform their concepts into creations - redefining what's possible using intelligent, efficient and high-performing TE products and solutions proven in harsh environments. Our 72,000 people, including over 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS - www.TE.com.
TE is now one of the largest sensor companies in the world, with innovative sensor solutions that help customers transform concepts into smart, connected creations. TE's unmatched portfolio of intelligent, efficient and high-performing sensor solutions are used for customers across several industries, from automotive, industrial and commercial transportation and aerospace and defense, to medical solutions and consumer applications.
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.
RESPONSIBILITIES & QUALIFICATIONS
* Manages the Regulatory Affairs function
* Develops global regulatory strategies
* Ensure compliance to 231 CFR 820, ISO 13485, MDD/MDR, 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 technical guidance and training to staff
* 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 (Change Control).
* 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).
* Bachelor's degree (BS, BA) (technical discipline preferred) with at least 3 years' medical device and 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
* Building Effective Teams
* Managing and Measuring Work
* Motivating Others
* Values: Integrity, Accountability,Teamwork, Innovation
* SET : Strategy, Execution, Talent (for managers)
As an Equal Opportunity Employer, TE Connectivity does not discriminate because of Race, Religion, Color, Age, Gender, Marital Status, Sexual Orientation, Gender Identity, National Origin, Physical or Mental Disability, or Protected Veteran Status, or any other categories protected by law.
Individuals with disabilities, who require a reasonable accommodation to complete this application and/or to participate in any part of the employee selection process, should contact us via e-mail at CorporateStaffing@TE.com or by phone (610) 893-9333.