Ensures compliance with regulatory agency regulations and interpretations.
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to colleagues. Provides regulatory guidance to product development teams and responds to product information requests. Provide Regulatory Affairs support during internal and external audits. You will be responsible for ensuring all changes are properly assessed globally and in a timely manner.
A minimum of a bachelor’s degree with at least 4 years of working experience within a regulated environment or equivalent is required – preferable medical device. You have knowledge or experience in Medical Device standards and regulations like ISO 13485, MDD/MDR and FDA. Excellent written, verbal communication and presentation skills is required. Knowledge of US and EU regulations is preferred. Experience in the preparation and submission of international regulatory filings is preferred. Previous experience working with cross functional teams within a matrix environment is required. Swedish speaking is preferred. Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products is preferred.
For more information please contact Shiva Hobbi Nowzari via email: email@example.com or mobile: 070-165 22 64
Due to GDPR we cannot receive any applications by email, so please submit your CV at www.pharmarelations.se
Read more about Senior Regulatory Consultant – Medical device here!