Regulatory Affairs Officer
ABOUT THE ROLE
Reporting to the Regulatory Affairs Specialist, the Regulatory Affairs Officer is responsible for supporting the company in the maintenance of the Regulatory Affairs function, achieving compliance with changing regulations and standards, and meeting company goals and targets by providing a high level of administrative support and co-ordination.
- Ensure adequate control of regulatory documentation is maintained.
- Ensure that confidential company information is protected.
- Maintaining Medical device Technical Files in line with Notified Body and regulatory requirements.
- Effective inputs to maintenance of the regulatory affairs function
- Monitoring of Post Market Surveillance Data
- Communicating with Device users, Group companies and customers as needed.
- Administration of Field Safety Corrective actions and Device Recalls
- Perform product trace activities
- Maintain records in relation to reportable events
- Attend meetings as required and take minutes
- Ensure that key information is relayed to the Regulatory Affairs Specialist as appropriate.
- Liaise effectively with other departmental staff.
- Generation of supporting documents for product registrations – Liaise with Export Team
- Perform product Risk management activities in line with regulatory requirements and maintain device risk files
- Perform audits of regulatory documentation
Critical Success Factors
- Providing administrative support during external and unannounced audits.
- Responding to internal requests for technical and/or regulatory information.
- Monitoring changes to regulatory legislation affecting the company.
- Supporting the Regulatory Affairs Specialist in achieving and maintaining compliance with EU MDD, MDR, REACH, WEEE, US FDA and other regulatory requirements in countries where our products are used.
- Assisting with device registrations and licence applications as required.
- Assisting the Regulatory team with medical device vigilance activities as required.
Product Development & R&D
- Ensure that regulatory requirements for product development work are documented for inclusion in product Technical Files.
- Input to requirements for documentation for national product registration activities.
- Assist with Risk Management activities, including generation of the risk management file, for new product development projects
- Assist with post market surveillance activities, including production and maintenance of PMS reports, monitoring and measurement of data and identification of triggers and action points.
- Administrative support for various projects, including working with departmental Managers (Quality, Marketing, Production) and external contractors/suppliers to ensure required documentation is produced on schedule and appropriately retained.
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy.
- To adhere to the company’s Quality policy and Environmental policy.
- To undertake other duties as may be reasonably required.
- Proven experience in a similar role
- Proven experience with Microsoft office suite
- Proven experience in a manufacturing environment
- Previous experience conducting risk assessments
- Degree educated in Law, Business or Science
- Knowledge of MDD, MDR, ISO13485 and/or ISO14971
KEY WORKING RELATIONSHIPS
- Group Operations
- Group R&D
- Regulatory authorities
- Notified bodies
- Ability/willingness to develop within the role
- Ability/willingness to attend training courses in relation to the role and the needs of the department
- Ability/willingness to travel to other Eakin Group sites as needed
Resilience – Can work under pressure, remains calm, thinks clearly, and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and does not dwell on past events.
Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Following Directions – Is motivated to accept and comply with standards and instructions and has a strong conscience about delivering what is promised or expected. Does not like letting people down and works productively in cooperation with, and support of others.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.