Job Overview:
As a key member of our team, the Senior Regulatory Affairs Specialist will oversee all regulatory activities, including product certification and compliance. This role requires expertise in managing complex regulatory processes, ensuring timely submissions, and maintaining accurate records.
Key Responsibilities:
* Develop and implement regulatory strategies to ensure compliance with international regulations
* Collaborate with cross-functional teams to prepare and submit regulatory documents
* Maintain technical files for cleared products, ensuring accuracy and completeness
* Support the development and implementation of quality management systems
* Stay up-to-date with changing regulatory requirements, adapting strategies as needed
Requirements:
* Advanced degree in a relevant field, such as life sciences or engineering
* Significant experience in medical devices, preferably in regulatory affairs
* Expert knowledge of EU, UK, and FDA regulations, as well as international standards
* Strong analytical and problem-solving skills, with excellent communication and project management abilities
Benefits:
* Opportunity to work on challenging projects, driving business growth and innovation
* Collaborative work environment, fostering professional development and teamwork
* Competitive compensation package, including benefits and professional growth opportunities
Skills/Experience:
* Proven track record of successfully navigating complex regulatory environments
* Excellent understanding of regulatory frameworks, including REACH and CE marking