Manager, Regulatory Affairs

Health & Home USA•Marlborough, MA

21h•Hybrid

About The Position

Manager, Regulatory Affairs at Helen of Troy Nevada Corporation in Marlborough, MA Manage regulatory requirements for new projects and changes to existing products. Work with cross-functional team consisting of engineering, marketing and quality to develop regulatory plans for key consumer products for US and international. Prepare regulatory submissions (510K, De Novo) for US FDA, Health Canada and other regulatory agencies. Communicate with regulatory agencies regarding pre-submission strategies, submission related questions and additional information or responses as requested by the FDA. Maintain Technical Files, permits, registrations and licenses. Review Engineering Change Requests (ECR) and make disposition per the appropriate SOP for full range of products. Manage periodic review of the procedures to ensure continuity with the QMS requirements. Support Certification audits and Management reviews as well as Global Supplier Review Board Meetings. Alert upper management of any issues or potential problems. Create or revise any procedures to implement existing quality management system to ensure compliance with 21CFR 820, MDSAP, ISO 13485, Canadian Medical Device Regulations, EU Medical device regulations and provide input to Asia Pacific for compliance to local regulations. Coordinate CAPA’s for major customers and suppliers and drive them to completion. Develop and revise labeling, advertising, promotional and scientific materials and publications for marketed products in support of the assigned product categories (specifically related to FDA, EPA, FTC, CPSC). Collaborate with the marketing managers on labeling development and revisions to assure compliance with the government requirements. Keep abreast of all the requirements pertaining to each product category. Supervise Regulatory Documentation Coordinator and Independent Contractors to accomplish their goals and objectives: training, internal audits, materials management and other special projects.

Requirements

Bachelor’s degree in Regulatory Affairs, Medical/Health Informatics, or closely related sciences discipline and two (2) years of experience in regulatory affairs for medical devices in federally controlled industry specifically in pre-market submissions; procedure writing; post market activities (CAPA); labeling review and ad/promo; and with MS Office, SharePoint and Smartsheet.
Subject to drug test and background check.
Hybrid office/home work schedule.

Responsibilities

Manage regulatory requirements for new projects and changes to existing products.
Work with cross-functional team consisting of engineering, marketing and quality to develop regulatory plans for key consumer products for US and international.
Prepare regulatory submissions (510K, De Novo) for US FDA, Health Canada and other regulatory agencies.
Communicate with regulatory agencies regarding pre-submission strategies, submission related questions and additional information or responses as requested by the FDA.
Maintain Technical Files, permits, registrations and licenses.
Review Engineering Change Requests (ECR) and make disposition per the appropriate SOP for full range of products.
Manage periodic review of the procedures to ensure continuity with the QMS requirements.
Support Certification audits and Management reviews as well as Global Supplier Review Board Meetings.
Alert upper management of any issues or potential problems.
Create or revise any procedures to implement existing quality management system to ensure compliance with 21CFR 820, MDSAP, ISO 13485, Canadian Medical Device Regulations, EU Medical device regulations and provide input to Asia Pacific for compliance to local regulations.
Coordinate CAPA’s for major customers and suppliers and drive them to completion.
Develop and revise labeling, advertising, promotional and scientific materials and publications for marketed products in support of the assigned product categories (specifically related to FDA, EPA, FTC, CPSC).
Collaborate with the marketing managers on labeling development and revisions to assure compliance with the government requirements.
Keep abreast of all the requirements pertaining to each product category.
Supervise Regulatory Documentation Coordinator and Independent Contractors to accomplish their goals and objectives: training, internal audits, materials management and other special projects.