Senior Regulatory Specialist

About the role

The Sr. Regulatory Specialist will support in the coordination of regulatory guidance and filings for medical devices, wellness devices, wearables, and mobile applications worldwide. They will manage regulatory affairs activities, including labeling, advertising, and promotional materials, and scientific publications for marketed products in support of assigned product categories. This role will also ensure compliance with US, Canadian, and Latin American government requirements for commercial and post-marketing activities.

Responsibilities

• Support in the coordination of regulatory guidance and filings for medical devices, wellness devices, wearables, and mobile applications worldwide.
• Manage regulatory affairs activities associated with development and revision of labeling, advertising, and promotional materials and scientific publications for marketed products in support of the assigned product categories.
• Ensure compliance with US, Canadian, and Latin American government requirements for commercial and post-marketing activities.
• Maintain Helen of Troy and relevant affiliates in compliance with government requirements for the imported and distributed products in the US, Canada, and Latin America (e.g., permits, licenses, registrations, and labeling).
• Review Engineering Change Requests (ECRs) and assess if changes to products are significant.
• Work closely with Europe and Asia regulatory affairs managers to provide and obtain the required documentation for product registrations in different global regions.
• Compile and submit traditional and/or special 510k’s through the FDA’s online database.
• Serve as the Helen of Troy contact person for regulatory agencies.

Requirements

• Understanding of ISO 13485 and ISO 9001 for quality management requirements.
• Ability to understand and interpret regulatory standards.
• Ability to communicate with external agencies such as the Federal Drug Administration.
• Strong attention to detail.
• Track and maintain registration periods to meet registration dates and follow-ups for completeness for a large group of registration.
• Excellent verbal and written communication skills.
• Flexibility to manage multiple projects for multiple internal customers.
• Certification in Regulatory Affairs for Medical Devices preferred.

Qualifications

• Bachelor’s degree in a relevant field.
• 4+ years of experience in regulatory medical devices.
• Authorized to work in the United States on a full-time basis.

Skills

• Understanding of ISO 13485 and ISO 9001 for quality management requirements.
• Ability to understand and interpret regulatory standards.
• Ability to communicate with external agencies such as the Federal Drug Administration.
• Strong attention to detail.
• Track and maintain registration periods to meet registration dates and follow-ups for completeness for a large group of registration.
• Excellent verbal and written communication skills.
• Flexibility to manage multiple projects for multiple internal customers.
• Certification in Regulatory Affairs for Medical Devices preferred.
• Competence in Microsoft Office Suite, notably, Excel, Word, and PowerPoint.

Benefits

• Salary + Bonus
• Healthcare
• Dental
• Vision
• Paid Holidays
• Paid Parental Leave
• 401(k) with company match
• Basic Life Insurance
• Short Term Disability (STD)
• Long Term Disability (LTD)
• Paid Time Off (PTO)
• Paid Charitable (volunteer) Leave
• Education Assistance