Regulatory Affairs Expert for Global Product Compliance
vor 1 Monat
We are seeking a highly skilled Regulatory Affairs Associate to join our dynamic team in ensuring compliance with regulatory requirements and supporting the global registration and approval process for our products.
Key Responsibilities:- Manage and maintain product registrations and submissions for global markets
- Prepare and review regulatory documentation and technical files
- Communicate with regulatory agencies and authorities
- Monitor and stay up-to-date on relevant regulatory changes and requirements
- Contribute to the development and implementation of regulatory strategies
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
- Minimum 3 years of experience in Regulatory Affairs within the Medical Device or Pharmaceutical industry
- Strong knowledge of global regulatory requirements, including FDA, EMA, and other regional regulatory bodies
- Experience with product registrations and submissions in multiple countries
- Excellent written and verbal communication skills
- Strong attention to detail and organizational skills
- Ability to work independently and as part of a team
- Bachelor's degree in a relevant field, advanced degree preferred
- Fluency in English, additional languages a plus
This is a rare opportunity to get in at the ground floor of an exciting company with continued expansion. The successful candidate shall be able to make the role their own and build their position with the company. This is a small to medium-sized company with an excellent culture and a family environment feel. We offer a leading salary with high bonus (20%) and benefits.
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