**Regulatory Specialist Opportunity**
* We are seeking a skilled Regulatory Specialist to join our team. The successful candidate will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations.
The ideal candidate will have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. They will be an enthusiastic self-starter with a willingness to be a hands-on contributor, possessing excellent organisational skills and the ability to balance immediate vs long-term priorities.
This role requires a thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820 and supporting standards. Experience working directly with regulatory agencies and strong problem-solving and communication skills are essential.
Key Responsibilities:
* Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
* Assist in the implementation of MDSAP within the organisation.
* Support the team to obtain / retain country-specific regulatory registrations on a global basis.
Benefits:
* Competitive salary and benefits package.
* Hybrid working arrangements.
* Opportunities for professional development and growth.
Requirements:
* Bachelor's degree in Engineering or Science.
* Minimum 3 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.