Regulatory Affairs Expert Opportunity
We are seeking a highly skilled Regulatory Affairs Specialist to play an active role in developing the regulatory strategy for medical device companies.
The ideal candidate will have extensive knowledge of quality management systems, design controls per ISO 13485, and current International and European regulations/standards.
This position offers a unique opportunity to work on novel cardiovascular devices and be part of a dynamic team.
Key Responsibilities:
* Support the creation and maintenance of product design and technical documentation in compliance with relevant regulations and standards.
* Provide guidance to and coordinate inputs from technical experts on each design project.
* Develop and submit high-quality clinical and regulatory files to regulatory agencies.
* Organize and maintain regulatory and clinical submissions with regulatory authorities and clinical investigation sites.
* Coordinate gap assessment activities and stay up-to-date with changes in applicable regulatory requirements and standards.
* Assist the company in preparing for inspections by notified bodies and regulatory authorities.
* Implement and maintain a robust quality system in accordance with ISO 13485, including risk management.
* Coordinate Adverse Event reporting to regulatory authorities.
Requirements:
* Bachelor's degree in science, engineering, or a related field.
* Proven track record in a similar role with a minimum of 5 years in medical device Regulatory Affairs.
* Extensive knowledge of quality management systems, design controls per ISO 13485, and current International and European regulations/standards.
* Experience in design, verification, and process validation processes.
* Prior experience and knowledge in GMP, process validation, change control, CAPA, and electronic document control systems.
* Good leadership and project management skills, with the ability to build and manage a small team.
Preferred Qualifications:
* Experience in people management and development.
* Excellent verbal and written communication skills.