Regulatory Affairs Specialist

Title: Regulatory Affairs Specialist - EMEA

POSITION SUMMARY

Regulatory Affairs Specialist for EMEA region responsible for all things Regulatory in the region, including but not limited to ingredient review, marketing collateral review, product registrations, and label reviews. Understands, implements, and maintains the quality policy. Ensures compliance to and demonstrates knowledge of site and division-level policies and procedures.

SUPERVISORY RESPONSIBILITIES

This position has no supervisory responsibilities for this role.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for regulatory activities of LW EMEA countries to launch and secure the products in the markets.
• Basic understanding of laws and regulations of the responsible EMEA countries.
• Assisting the department head in responding to all product-related inquiries and actions by regulators and internal departments.
• Assisting in preparing and filing necessary documentation for applications with international government agencies for product registration and coordinating advice on technical aspects of product labeling, product dossiers, claims substantiation/localization, and product registrations.
• Reviewing marketing materials for compliance with advertising law and scientific substantiation.
• Reviewing product labels for compliance with local labeling regulations for medical devices, general wellness, supplements, and cosmetics.
• Manage Regulatory tools and trackers.
• Perform other related duties assigned by department head.
• Obtains supervisory regulatory review on submission documents before submission to government agencies.
• Signs off at the team level within delegated parameters for change control.
• Releases authority for labeling/sales/promotional materials.
• Share knowledge with others in the department.

QUALIFICATIONS AND EXPERIENCE

• Bachelor's degree in business or related field or 4-6 years of experience in regulatory affairs in medical device, cosmetic, food, and dietary supplement field in EMEA. Experience in cosmetic, dietary supplement contract manufacturing a plus.
• Proficiency in Microsoft Suite required.
• Strong attention to detail and time management skills.
• Excellent communication skills, both written and oral.
• High level of observation must be able to learn quickly with an ability to be self-sufficient, motivated and to work independently.
• Bilingual proficiency is preferred but not required.

Work Environment & Physical Demands

LifeWave will operate as an in-office organization, and all employees are required to work onsite in alignment with corporate policy. While performing the duties of this job, the employee is regularly required to work at a computer workstation and be mobile within the office. Occasional movement of up to 25 pounds may be required.

LifeWave is committed to creating an inclusive workplace that values diversity and promotes equal opportunities for all. We embrace the principles of the Americans with Disabilities Act (ADA) and strive to provide reasonable accommodations to qualified individuals with disabilities.

In our pursuit of building a diverse and talented team, we encourage candidates of all abilities to apply for positions at LifeWave. If you require accommodation during the application or interview process, please inform our HR department, and we will work with you to ensure your needs are met.