Regulatory & Documentation Specialist

5 days ago

Plainville, United States Synerfac Technical Staffing Full time

Job Summary - Regulatory & Documentation Specialist

Work for a growing Connecticut medical device company. The Regulatory Affairs & Documentation Specialist is responsible for formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations. Assists with technical/regulatory aspects of product development. Under general supervision of the Operations Department and cross supporting Marketing and Quality Departments, to provide the support required for a successful launch of new & existing products for both domestic and international distribution.


INDUSTRY EXPERIENCE REQUIRED - Medical Devices Specific.


Responsibilities & Duties

* Prepares documentation for all international product registrations

* Stays up to date on all international medical device regulations (EU MDD/MDR and other territories) including formulations, labeling and packaging related changes.

* Maintain all registrations and certificates for all international registrations.

* Provide correspondence to international distributors on localization matters regarding registration and compliance.

* Prepare all related documents required for export registration, i.e. product composition, packaging declarations, manufacturing certificates etc.

* Review regulation changes annually and take any required action ·

* Creates and maintains technical documentation files for both domestic and international regions. · Obtain technical/regulatory documentation from raw material vendors. ·

* Compiles and updated documentation for global product registrations. · Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.

* Reviews labeling to ensure compliance with domestic and international standards and regulations and consistency with regulatory submissions/approvals.

* Assists with maintenance of processes and procedures related to Regulatory Affairs activities; develops SOP internal procedures and tools. ·

* Assists with investigations and executes corrective actions for Quality Incidents and Corrective and Preventive Actions. ·

* Organizes and maintains hard copy and electronic department files. · ·

* Responds to general product and regulatory inquiries from internal stakeholders

* Carries out duties in compliance with established business policies.


Qualifications

* 1-3 years experience in Regulatory Affairs in the medical device space.

* Knowledgeable with international regulations and be able to prepare documentation & communicate with International regulatory consultants preferred.

* Technical Writer.

* Document Control/Batch Records / Change Control.

* Must have Microsoft Professional edition software skills.

* Must have project management skills.

* Knowledge of cGMP of medical devices.

* Demonstration of continual education (through membership in recognized organizations, seminars attended, & certifications.

* Strong time-management, organizational, planning people and leadership skills. Advanced PC Knowledge i.e. MS Office Suite (Excel, Word, Outlook) and management system is required.

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