Medical Device Company who are looking to recruit a Regulatory Affairs Specialist.
This person will be responsible for designing, managing and executing the company’s regulatory strategy, ensuring that the company meets applicable medical device legislations and ensuring that the company’s products meet all applicable regulatory requirements.
Duties & Responsibilities
Propose and execute regulatory approval strategies, including preparation and maintenance of all regulatory submissions.
Design, draft, and lead regulatory filing submissions to various international competent authorities.
Lead and execute the communication with competent authorities including preparation of technical dossiers for pre-submission meetings, submissions, reports and responses to questions and inquiries.
Perform on a continuous basis the regulatory watch in the applicable jurisdictions and act accordingly to ensure continuous compliance to applicable
Work closely with their Innovation R & D, project and product teams
Work closely and build relationship with their partners
Develop an effective worldwide regulatory Strategy with clear recommendations to their Management.
Qualifications and Skills
Engineering / Life Science Degree or equivalent
Five (5) to ten (10) years of regulatory affairs experience in the medical device industry
Excellent communication skills (written and verbal) in English and at least one other European Language preferably French
Proven experience in preparing and reviewing submission packages and interaction such as EU, FDA, CNDA, PMDA etc…
An in-depth understanding of various standards and associated requirements such as ISO 13485 etc…