Senior Regulatory Specialist

REMOTE: Senior Regulatory Specialist - Medical Device Industry

Do you have a passion for regulatory compliance and a drive to ensure the safety and effectiveness of medical devices?

Our client, a leading consultancy in the medical device industry, is seeking a highly skilled and experienced Senior Regulatory Specialist to join their dynamic team. As a Senior Regulatory Specialist, you will play a crucial role in ensuring compliance with regulatory requirements and standards.
Our client is looking for experience in one of the following:

Active medical devices, software as a medical device (SaMD), cybersecurity, and AI/machine learning technologies.

Key Responsibilities:

• Collaborate with cross-functional teams and companies to develop and implement regulatory strategies for new and existing medical devices
• Conduct risk assessments and ensure compliance with relevant standards and regulations, including 60601 and 62304
• Develop and maintain regulatory documentation, including technical files, design dossiers, and regulatory submissions
• Stay up-to-date with the latest regulatory requirements and industry trends, providing guidance and support to internal stakeholders
• Support regulatory audits and inspections, liaising with regulatory authorities as necessary
• Provide regulatory input throughout product development lifecycle, ensuring compliance from concept to commercialisation

Desired Skills and Experience:

• Proven experience in regulatory affairs within the medical device industry, focusing on either active medical devices, software as a medical device, and emerging technologies such as AI/machine learning
• Strong knowledge and understanding of relevant standards and regulations, including 60601, 62304, and cybersecurity requirements
• Excellent analytical and problem-solving skills, with the ability to interpret complex regulatory requirements and provide practical solutions
• Strong communication and interpersonal skills, with the ability to interact effectively with internal teams, regulatory authorities, and external stakeholders
• Detail-oriented mindset, with the ability to manage multiple priorities, meet deadlines, and ensure accuracy in regulatory documentation
• Relevant qualifications in regulatory affairs or a related field are highly desirable

Perks of Joining Our Team:

• Salary ranging from £50,000 to £70,000 per annum, depending on experience
• Permanent, Full time position with full remote working available
• Opportunities for professional growth and career development

To apply for the position of Senior Regulatory Specialist, please submit your CV and cover letter outlining your relevant experience and qualifications. We look forward to reviewing your application!

Please note that due to the high number of applications, only successful candidates will be contacted.

Our client is an equal opportunity employer and values diversity in the workplace. We strongly encourage individuals from underrepresented groups to apply. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, or protected veteran status.

Adecco is a disability-confident employer. It is important to us that we run an inclusive recruitment process to support candidates with any disabilities and encourage applicants of all backgrounds and perspectives to apply. Adecco is committed to building an inclusive, supportive environment for you to explore the next steps in your career