- Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada and Europe.
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications, etc.
- Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required.
- Assist in preparing responses to regulatory authorities' questions within assigned timelines. 4. Stay abreast of regulatory procedures and changes in the regulatory climate.
- Assess device-related incidents/complaints for medical device reporting requirements.
- Handle recalls and field actions, if required.
- Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.
- Assist in audit preps
- Responsible for communicating with agencies for any Notification, Field actions, Adverse Events, Significant/Non-Significant Changes, etc
- Have a detailed understanding of Product life cycle management
- Bachelor's degree (BS, BA)
- Currently have or pursuing a Master in Regulatory Affairs
- 4 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.
- Multi-tasker and Quick Learner
- Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
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regulatory affairs specialist iii - PLYMOUTH, United States - TE Connectivity
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
Regulatory Affairs oversees compliance activities for customers. This covers reporting, tracking and improving compliance with regulations and laws pertaining to the manufacture, marketing and development of regulated products.
What you will be doing:
This will be a HYBRID role, onsite attendance will be required to meet with the TEam as needed.
What your background should look like:
Competencies
SET : Strategy, Execution, Talent (for managers)
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 enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more at and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).
COMPENSATION
• Competitive base salary commensurate with experience: $92,480 – $138,720 (subject to change dependent on physical location)
• Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
• Total Compensation = Base Salary + Incentive(s) + Benefits
BENEFITS
• A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
EOE, Including Disability/Vets
