Purpose
The main purpose is to represent the RAQA Department in cross-functional project teams activities and, the Company, when working directly with relevant regulatory authorities on regulatory issues and international standards compliance requirements. This also includes facilitation in preparation of meetings with regulatory authorities and certification bodies with regards to technical files and products submissions.

The role involves the implementation of the regulatory/quality management system within the core and support operations of the Company and provide strategic input and regulatory advice on new product development programs and changes that impact products portfolio.

Regulatory research and analysis to keep abreast of the regulatory and standards landscape for medical devices is an essential part of the role.

Requriments
•Qualifications – BSc/BA degree in scientific discipline from an accredited college or university or equivalent. Advanced degree preferred
•Experience – minimum 7 years in relevant medical devices industry experience, regulatory affairs and or quality assurance. Proven track record of 5 years minimum in people/department management
•Documented training on current medical device standards and regulations is an asset (e.g., MDSAP, EU MDR, ISO 13485, etc.).
•Demonstrated understanding of laws, regulations, standards, and guidance and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities. Knowledge of UK, USA, EU and Asean regulatory requirements essential
•Experience in working with quality aspects of medical device and GMP in general. Knowledge of Cybersecurity Management and Software contained in Medical Device an advantage
•Proven ability to successfully interact with regulatory authorities and manage major submissions and critical projects to meet deadlines
•Proven track record and experience with regulatory submissions with a thorough understanding of country-specific regulations
•Implementation of Regulatory/Quality along with medical device product development and manufacturing experience is preferred
•Self-motivated, with the ability to work proactively utilising own initiative
•Excellent communication skills, (written and verbal), excellent interpersonal and presentation skills
•In-depth knowledge of International Standards, Regulations, and Medical Devices Directives, and ability to interpret and apply GMP, guidelines, and best practices
•Strong scientific/analytical/problem-solving skills, attention to detail, quality/customer focus
•Willingness and ability to collaborate with and influence other groups in a positive, team-based environment
•Good IT skills in MS Office 365 Suite, MS Visio, MS Project, MindManager Mind Mapping Tool, Quality Tools and Techniques
•Hands-on approach, with a ‘can do’ attitude managing multiple projects and deadlines
•Ability to identify compliance risks and escalate when necessary

 

Benefits package
20 days holidays
Pension Scheme – 5% Company/3% Employee
Private Healthcare Scheme option
Free car parking

Please note no recruitment agencies
Must be eligible to work in UK
Job Types: Full-time, Permanent
Please send CV and cover letter to humanresources@oxfordbiodynamics.com