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Senior Regulatory Affairs 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 (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.   

 

Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia.  http://www.creganna.com/

 

The Senior Regulatory Affairs Specialist will provide guidance to product development teams engaged in the design of minimally invasive cardiovascular medical devices that are legally manufactured by Creganna Medical.  He/she will ensure that compliance to regulatory requirements is demonstrated and will provide on-going regulatory support through the product life cycle. This is a Galway based position. The Snr RA Specialist will report to the RA Manager.

Responsibilities

•    Provides all pre-approval regulatory affairs activities in support of medical device product development
•    Provides input to strategic regulatory insight to support product development planning
•    Supports planning, preparation, and submission of regulatory medical device submissions for EU MDR Class III and Class II certification
•    Supports planning, preparation, and submission of regulatory medical device submissions for US Class II products including 510(k) submission activity and license amendment submissions to Heath Canada
•    Provides support for international registrations performed by 3rd party.
•    Provides all post-approval regulatory affairs activities in support of medical device products throughout their commercial life. Reviews product and process changes.
•    Creates and maintains regulatory filings.  Ensures that Design Dossiers, Technical Files and Clinical Evaluation Reports are updated per SOP requirements.
•    Conducts complaint adverse event reporting assessments and reporting activities for CTM legally manufactured products.
•    Updates quality system as required for regulatory specific changes.
•    Participates in and assists with external regulatory agency audits, as required.
•    Assist RA Manager with Field Safety Corrective Action Notifications and Recordkeeping

What your background should look like:

•    Must have a minimum of 3-5 years of medical device regulatory affairs experience with a Bachelor’s degree or higher in a related discipline. Bachelor's degree in science, math, engineering, legal or medical fields is preferred. RAC Certification is preferred.
•    Demonstrated knowledge of the Medical Device Directive MDD 93/42/EEC, US FDA 21 CFR Regulations, ISO 13485 and ISO 14971 at a minimum. Basic knowledge of MDR 2017/745, UKCA Mark will be an advantage.
•    Must be able to work independently with minimum supervision and also as a member of a cross-functional team; exhibiting strong attention to detail, multi-tasking and time management skills to meet high expectations and tight deadlines.
•    Strong interpersonal skills and the ability to communicate well both internally and externally to Creganna.
•    Demonstrated computer skills – word processing, spreadsheets, internet research and other applicable software programmes (Microsoft Word, Excel, PowerPoint).
•    Must have excellent report writing skills; the ability to deliver a clear, precise message appropriate to the target audience

 

Competencies

Values: Integrity, Accountability,Teamwork, Innovation
Location: 

GALWAY, G, IE, H91 VN2T

City:  GALWAY
State:  G
Country/Region:  IE
Travel:  10% to 25%
Requisition ID:  77369
Alternative Locations: 
Function:  Quality


Job Segment: Regulatory Affairs, Law, Engineer, Compliance, PLM, Legal, Engineering, Management

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