My client is a leading global MedTech company who has been around for over 100+ years. They specialise in IVD as well as in AI. They have created a fun and collaborative environment and due to their success, they are growing at an exciting rate! They are seeking a Senior Regulatory Affairs Specialist to join them in nurturing and growing the business.
Essential Duties and Responsibilities
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle
- Regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance
- Plans and prepares product related medical device submissions with the company internal or external organizations according to regulatory requirements
- Submits required documentation/information to local authorities (e.g., USA FDA, EU NB) or the company internally
- Advises project steering groups on regulatory strategy and requirements for specific new products/solution
- Identifies potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project
- Identifies, analyzes and implements country specific requirements necessary for product related submission
- Performs review of promotional material and products being introduced into a market for regulatory compliance according to country specific requirements
Qualifications (Education, Certifications and/or Experience)
- 8+ years of regulatory experience in medical tech industry
- BS/MS degree or equivalent experience. Related engineering, science, regulatory or medical disciplines preferred
- Strong organizational, negotiating, and problem-solving skills
- Excellent written and oral English communication skills; demonstrated public speaking skills
- Ability to work independently in fast-paced environment and adapt to change
- Willing to travel up to 10%
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If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything