Senior Principal Regulatory Specialist

4 weeks ago

London, United Kingdom Halian Technology Limited Full time

This is a fantastic opportunity for a Senior Principal Regulatory Specialist to join an established, global Medical Device company based near the South Coast in Hampshire. The business operates with hybrid flexibility of 3 days onsite/2 remote, and flexi hours too The position is offering a six-figure salary with amazing benefits including 15% bonus, healthy pension (5% personal, 9% company contribution), car allowance, and more. They are also able to offer relocation for the right candidate. What youll be doing: You will be responsible for market access and maintenance of business regulatory activities for a designated sub-region within EMEA, which includes EU Countries, CIS, ACE, and MENA. This role supports the MDD/MDR, CIS, and ACE Country Regulations and heavily interacts with the EMEA Commercial leadership team. You will provide expert regulatory partnership and direction for products from concept to launch and post-market, and this role involves leading the creation, development, and implementation of global/regional regulatory affairs procedures, ensuring compliance with regulatory requirements, and maintaining the companys regulatory compliance status. In addition, youll also play a significant role in technical audits and regulatory intelligence processes. Skills required: Strong leadership attributes and ability to influence decision-makers. In-depth understanding of ISO 13485, MDSAP, MDD, MDR, and other relevant regulations. Excellent attention to detail, organisational, and technical writing skills. Proficient in MS Office applications and relational database systems. Ability to work effectively in multinational/multicultural environments. Strong communication skills and ability to manage multiple priorities. Experience: 8-12 years of experience in the regulated medical device industry. Extensive experience with regulatory submissions and technical documentation. Proven track record of managing complex regulatory projects and audits. Experience in electronic document management systems. Education: Bachelors degree in a scientific or technical discipline required. Advanced degree and Regulatory Affairs Certification highly desirableTPBN1_UKTJ

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