Global Regulatory Expert for Medical Devices and Consumer Goods
5 days ago
We are seeking a highly skilled Global Regulatory Specialist to join our Quality and Regulatory team at Frida, a leading manufacturer of medical devices and consumer goods. This role will be responsible for ensuring compliance with regulations across various regions, including the US, Canada, Mexico, EU, UK, Switzerland, and Saudi Arabia.
As a Global Regulatory Specialist, you will play a key role in managing regulatory responsibilities associated with product development, manufacturing, and commercialization. You will develop and implement regulatory strategies and plans to support the introduction of new products, prepare and review international regulatory submissions, and liaise with external parties to ensure compliance in global markets.
Your responsibilities will include:
- Regulatory Compliance: Ensure that all products meet regulatory requirements in each market, including FDA, GxP, and CPSC regulations, as well as those of other countries.
- Product Registrations: Manage product registrations, license renewals, and resolves compliance issues.
- International Regulatory Affairs: Represent international regulatory interests on cross-functional project teams and provide input on labeling requirements, translation materials, and claims reviews.
- Change Management: Evaluate change proposals for international regulatory impact and maintain effective communication within the RA/QA group and cross-functional business partners.
To succeed in this role, you will need:
- Bachelor's Degree: In Science, Engineering, or a Pharmaceutical discipline.
- Regulatory Experience: Minimum 3 years of experience in international regulatory affairs, including submissions, license renewals, and technical file preparation.
- Technical Skills: Proficiency in 21 CFR 820, ISO 13485, MDSAP, and European Medical Device Regulation (2017/745).
- Soft Skills: Strong communication and organizational skills, ability to work independently and collaboratively, and result-oriented approach.
Frida offers a competitive salary of $120,000 - $150,000 per year, based on experience, plus benefits, including health insurance, 401(k) matching, and flexible paid time off.
The ideal candidate will have a passion for regulatory compliance, excellent analytical skills, and the ability to work effectively in a fast-paced environment. If you are a motivated and detail-oriented professional looking to take your career to the next level, we encourage you to apply for this exciting opportunity.
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