
Regulatory Support Specialist
4 days ago
TN Sweden is a pioneering medical device business dedicated to harnessing cutting-edge biotechnological manufacturing methods to drive innovation in biomaterials.
As a Medical Affairs Manager, you will contribute to this mission by providing medical and scientific support for the company's products, collaborating with management, regulatory affairs, and commercial teams to ensure product safety and effectiveness.
Your expertise will be invaluable in developing and executing medical affairs strategies, compiling regulatory submissions, and evaluating scientific literature.
You will also be responsible for creating scientific training materials and presenting complex data to diverse audiences.
The ideal candidate will have a strong understanding of drug and medical device development and regulatory procedures, as well as exceptional written and spoken communication skills in English.
- Key Responsibilities:
- Plan and oversee scientific and clinical studies to meet regulatory and marketing needs.
- Work closely with the regulatory affairs team to compile regulatory submissions.
- Develop and execute medical affairs strategies and plans.
- Evaluate and assess relevant scientific literature.
- Create and provide scientific training materials.
- Requirements:
- Possession of an MD, PhD, PharmD, or similar advanced degree in a relevant scientific field.
- Previous experience in medical affairs, scientific communications, or clinical research.
- Strong understanding of drug and medical device development and regulatory procedures.
- Exceptional written and spoken communication skills in English.
- Able to interpret and present scientific data to diverse audiences.
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