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Sr. Regulatory Specialist

  • Anywhere

Company :
TE Connectivity

Location :
Andover, Minnesota

Expiry Date :
Mon, 21 Dec 2020 23:59:59 GMT

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Description :
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. Responsibilities: – Develops global regulatory strategies – Ensure compliance to 21 CFR 820, ISO 13485, MDD, EU 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 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 – Conducts regulatory impact assessments on product and manufacturing changes for compliance with applicable regulations – Ensure annual report and annual MDL and MDEL renewal is conducted with Health Canada – Ensure annual Establishment Registration and Device Listings are up to date for manufacturer, contract manufacturers and sterilization sites. – Ensure the EU Technical Files are maintained and up to date – Ensure the PMS and Clinical Evaluation is conducted in line with MDD and EU MDR requirements. – Ensures adverse event reporting assessments are completed and any subsequent MDR / vigilance / MPR reports are filed as applicable – 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 – Manages any Regulatory relates CAPAs – Supports the CAPA, Management Review and External Audit processes What your background should look like: – Must be US person or PRC holder due to access to products and Bachelor’s degree (BS, BA) (Regulatory Affairs discipline preferred) – At least 5-7 years’ Regulatory experience – Extensive knowledge of the regulatory requirement for medical devices (ISO 13485, 21 CFR 820, MDD, EU MDR and other regulatory requirements) – 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 – 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.). – Ability to travel approximately 10%, including international CompetenciesValues: 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 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.