Description
Description of the Job Responsibilities- Management of company's Regulatory Affairs activities to meet the requirements of the Business and the regulatory compliance of the business and its medical devices.
- Compilation and authorisation of appropriate regulatory affairs policies, procedures and/or work instructions. Document Control (Team-Point user, compiler and reviewer).
- Review, interpretation and provision of guidance concerning:-
- HealthCanadaRegulations
- Australian TGA Regulations
- Japanese PAL requirements
- US FDA requirements
- European MDD requirements
- ISO 13485
- FDA 21 CFR Part 820
- REACH requirements
- Management of Regulatory Affairs personnel and the assignment and monitoring of tasks/activities to such personnel.
- Management, update and currency of the company's technical files/design dossiers
- Communication with Notified Body with respect to new and/or updated product designs
- Communication with other regulatory authorities, either directly or through Market Authorization Holders or Distributors with respect to regulatory device clearance in non-EU markets
- Involvement and input in all stages of the design process including planning, development, pre-clinical, clinical, manufacturing, packaging, labeling, sterilisation, marketing technical support and post market surveillance
- Involvement with the regulatory aspects and monitoring of any vigilance issues including the preparation of appropriate Field Safety Notices and the relevant communication with the Competent Authority, Notified Body and customers, in conjunction with Customer Services personnel
- Input into the Management Review process with respect to providing updates to new and/or changing legislation or regulation affecting the Company and its range of medical devices
- Review and authorization of the regulatory content of product-label artwork and relevant marketing literature
- Input, support and where appropriate, the management of regulatory related projects.
- Support the wider Quality & Regulatory department to ensure company and product compliance with relevant quality assurance and regulatory regulations.
- Member of the Aspen Internal Audit team.
- Contribute to discussions regarding departmental budget requirements, including relevant Capital Expenditure and routine departmental costs.
Relevant experience or qualifications required:
Essential Requirements
- Educated to degree or equivalent in a scientific discipline and/or regulatory affairs.
- Knowledge of national and international Medical Device legislation and regulations
- Proven previous experience in a medical device regulatory role
- Technical File/Design Dossier compilation, authorisation and maintenance
- Knowledge of and experience with ISO 13485 and /or FDA 21 CFR Part 820
Desirable Requirements
- Understanding of medical device clinical evaluation (ISO 14155 & Meddev 2.7.1)
- Understanding of medical device Post Market Surveillance (NB-MED 2.12/1)
- Understanding of medical device risk management (ISO 14971)
- Understanding of medical device biocompatibility requirements (ISO 10993)
- Understanding of Own-Brand Label (OBL) requirements
- Understanding of medical device vigilance requirements (Meddev 2.12-1)
- Understanding of medical device sterilisation requirements (ISO 11137 & 11135)
- Understanding of medical device design requirements and interaction with appropriate regulatory strategies for new and changed product-designs.
- Understanding of the Company interface with Notified Body and Competent Authority
- Member of a relevant professional institute
- Trained internal auditor
Person Specification
- Interpersonal (good communicator, able to work as part of a team)
- IT literacy (competent in MS Office applications)
- Numeracy and literacy (good with figures and writing)
- Time management and organisation (able to a manage and control simultaneous tasks)
- Project Management (ability to manage and lead projects)
- Analytical (gather, understand and report concisely on data)
- Results orientated (is driven to succeed)
- Good attention to detail
To find out more about Real please visit www.realstaffing.com