Job Description

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 CAPAs 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:

Bachelors 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.

Wage range: $117998.00 to $130000.00 per year

Apply to: . Please refer to job code REQ# R0005837

For more information about Helen of Troy visit . You can also find us on and

Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences thoughts cultures and backgrounds. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin age pregnancy genetic information disability status as a protected veteran or any other protected category under applicable federal state and local laws.

We will provide individuals with disabilities with reasonable accommodations to participate in the job application process. If you would like to request an accommodation please contact Human Resources at .

Founded in 1968 Helen of Troy is a prominent player in the global consumer products industry offering diverse career opportunities across North America South America Europe and Asia. We boast a collection of renowned brands such as OXO Hydro Flask Osprey Honeywell PUR Braun Vicks Hot Tools Drybar Curlsmith Revlon and Olive & June many of which rank #1 #2 or #3 in their respective categories making the Helen of Troy name synonymous with excellence and ingenuity.

At Helen of Troy our strategy involves acquiring brands that we can integrate and enhance amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally we are committed to providing innovative solutions tailored to consumers operational excellence global scalability and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry propelling our brands to unparalleled heights of success and recognition worldwide.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.

Required Experience:

Manager

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