Sr Regulatory Affairs Specialist

Job information Sr Regulatory Affairs Specialist from the Company Stirling Q&R Ltd, this latest Sr Regulatory Affairs Specialist job vacancy is located in the city Sheffield. This latest job opening is open to job seekers who have the latest education / graduate . Job Vacancies in this Leadership field have been opened and published up to the specified time.

Senior Regulatory Affairs Specialist

About the Company

Join a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and rigorous compliance with global standards. With a strong commitment to quality and regulatory excellence, they are at the forefront of developing safe and effective medical solutions that make a difference in healthcare worldwide.

About the Role

We are seeking a highly skilled Senior Regulatory Affairs Specialist to ensure our client's products meet all regulatory requirements across various international markets. This role involves leading regulatory initiatives, managing technical documentation, and liaising with regulatory bodies to secure product approvals. You will play a crucial role in guiding their regulatory strategy and ensuring compliance with evolving legislation.

Key Responsibilities:

• Lead the development, management, and maintenance of technical files and design dossiers
• Oversee the classification of medical devices and assignment of GMDN codes.
• Manage regulatory submissions for new market entries, including the preparation of country-specific technical reports.
• Administer regulatory aspects of new product development and communicate changes to the Notified Body.
• Act as the primary liaison with regulatory authorities and host audits.
• Provide regulatory guidance to cross-functional teams and senior management.
• Fulfill the role of Person Responsible for Regulatory Compliance (PRRC) as per MDR 2017/745.

Background/Experience:

• Bachelor's degree in life sciences, engineering, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in regulatory affairs within the medical device industry, preferably in orthopaedics/ implantables.
• Comprehensive knowledge of international regulatory requirements, including those in the UK, EU, North America, South America, the Baltics, and Asia-Pacific.
• Familiarity with quality management systems such as ISO 9001, ISO 13485, and relevant FDA regulations.
• Strong analytical and problem-solving skills, with the ability to manage multiple projects and meet tight deadlines.
• Proven leadership and team management abilities, with excellent communication skills.

Apply

If you are a dedicated regulatory affairs professional looking to make a significant impact in the medical device industry, we would love to hear from you.

Please submit your CV to apply for this exciting opportunity!

Job Types: Full-time, Permanent

Pay: £50,000.00-£60,000.00 per year

Benefits:

• Company pension
• Free parking
• On-site parking
• Work from home

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Sheffield: reliably commute or plan to relocate before starting work (preferred)

Application question(s):

• What experience do you have with Class III Medical Devices and how many years?

Education:

• Bachelor's (preferred)

Experience:

• Regulatory Affairs: 5 years (preferred)
• Medical Devices: 5 years (preferred)

Work authorisation:

• United Kingdom (preferred)

Work Location: In person