Job Title: Senior Regulatory Affairs Specialist
Ensure that the company's products and services comply with all relevant regulations and standards.
Responsibilities:
* Develop and execute regulatory strategies for product registration, approval, and compliance.
* Manage day-to-day regulatory activities, including multiple projects related to regulatory compliance enhancements.
* Prepare, maintain, review, and submit regulatory documents and applications to health authorities.
* Support the team in obtaining or retaining country-specific regulatory registrations globally.
* Implement MDSAP within the organisation and monitor compliance with national and international regulatory requirements and quality standards.
* Identify and assess potential regulatory risks and propose effective mitigation strategies.
Requirements:
* Bachelor's degree in Engineering or Science.
* Minimum 6 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.
* Thorough understanding of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CFR 820, and supporting standards.
* Proven track record of successfully managing projects to deadlines.
* Experience working directly with regulatory agencies.
* Strong ability to manage critical projects as part of an interdisciplinary team.