lifewave
Regulatory Affairs Manager - EMEA
Draper, Utah
Sponsorship not specifiedDetected 12 days ago
FDA RegulatoryMedical DevicesCommunicationTime ManagementRegulatory Affairs
About the role
- 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.
- SUPERVISORY RESPONSIBILITIES This position has no supervisory responsibilities for this role.
Responsibilities
- Perform other related duties assigned by department head.
- Obtains supervisory regulatory review on submission documents before submission to government agencies.
Requirements
- Ensures compliance to and demonstrates knowledge of site and division-level policies and procedures.
- Proficiency in Microsoft Suite required.
- High level of observation must be able to learn quickly with an ability to be self-sufficient, motivated and to work independently.
- 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.
- 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.
- 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.
- 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.
Nice to have
- Experience in cosmetic, dietary supplement contract manufacturing a plus.
- Bilingual proficiency is preferred but not required.
Skills
- Manage Regulatory tools and trackers.
- Strong attention to detail and time management skills.
- Excellent communication skills, both written and oral.
Benefits
- Reviewing product labels for compliance with local labeling regulations for medical devices, general wellness, supplements, and cosmetics.
Equal opportunity
- 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.
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This listing is sourced directly from lifewave's careers page and normalized into a canonical job model.