Job Title: Senior Regulatory and Requirements Specialist with Medical Devices Industry Experience
Report to: Global Regulatory and Requirements Team Manager
Location: Remote / Cork, Ireland
As a Senior Regulatory and Requirements Specialist (SRRS) with Medical Devices Industry Experience you will be working as part of our Global Regulatory & Requirements Compliance Team (GRCT). The GRCT is responsible for monitoring global regulatory developments, both enacted and proposed, as well as supporting information, such as guidance documents, on a wide range of topics, from product safety to environmental to occupational health & safety.
The SRRS with Medical Devices Industry Experience will be responsible for tracking regulatory developments globally (with a particular focus on Medical Devices) and entering this information into our online database ‘C2P’ in a structured format. The SRRS will also be responsible for providing an overview of the regulatory information and identifying key details such as when the measure enters into force & upcoming compliance deadlines.
The SRRS may also be required to enter requirements (extracted from Regulations and Standards) into the Requirements Management Platform (a part of C2P) in response to business & client needs.
Additionally, the SRRS will take on responsibility for assisting with the launch of the Medical Devices topic area in C2P, actively developing and deepening their knowledge of the area and answering queries on the content from within the team as well as externally e.g. the sales team & clients.
The SRRS will also assist in reviewing current medical device content globally in C2P and identify any gaps that need to be filled, in addition to ongoing monitoring and tracking of legislative developments in this topic.
The SRRS will also be expected to handle more complex research tasks and aid in researching answers to client queries which come through our “Ask Our Experts” function.
Key Responsibility Areas:
- Monitor regulatory developments for specified countries and product groups/categories with a specific focus on Medical Devices
- Ensure a comprehensive & reliable bank of sources of regulatory information is built up & maintained to ensure effective and optimal monitoring
- Own and maintain ‘Monitoring Issues’ for specified countries, ensuring sources of regulatory information & any useful information to aid monitoring is recorded and current
- Utilize automatic monitoring tools to maximize the efficient and prompt capture of regulatory information
Entry of Regulatory Information into C2P & Requirements Platform
- Enter regulatory and supporting sources into C2P in line with established data entry conventions
- Ensure all information uploaded is accurate & exhibits a keen attention to detail
- For Regulations, drafting of clear, well written, accurate summaries on key details in text, underpinned with an appreciation of clients’ needs
- Addition of regulatory updates concerning regulatory developments to C2P
- Review of daily email alerts via C2P on regulatory changes to existing Regulations and Standards to determine if new Requirements need to be added to Platform or existing Requirements should be updated
- Monitor regulatory developments for specified countries and product groups/categories via Regulatory Update and Expert Comments received via C2P alerts, ‘watching’ various C2P projects as well as various other online monitoring tools
- Ensure a comprehensive and reliable bank of sources of regulatory information is built up and maintained to ensure effective and optimal monitoring for responsible countries and product groups/categories
- Conduct research in the field of global regulations and standards, taking on more complex and technical research tasks, with a particular focus on global Medical Device regulations
- Conduct research in response to client queries on Medical Device regulations which come through our “Ask Our Experts” function
- Research and prepare specialized reports for clients
- Possess a strong knowledge and understanding of all areas of coverage in C2P database with particular emphasis on global Medical Device Regulations
- Assist with the launch of the Medical Devices topic area in C2P
- Assist in reviewing current medical device content globally in C2P and identify any gaps that need to be filled in C2P
- Ongoing monitoring and tracking of legislative developments in this topic
- Become the go-to person for the Medical Devices Topic area in C2P and answer queries on the content from within the team as well as externally via our “Ask Our Experts” function
- Help Compliance & Risks become recognized as a trusted source on Medical Device regulation and build brand recognition in this regard by the creation of articles, white papers, presentation of webinars related to Medical Devices
- Develop and maintain the Content Boundary Document (internal document) and Topic Sheet (external document) for the Medical Devices Topic area and assist in the preparation of any other relevant information documents
- Provide guidance & answer queries on the Medical Devices Topic both to within the team and externally e.g. the sales team & clients
- Actively engaging in ongoing changes to GRCT processes in order to improve team efficiency as well as pro-actively contributing ideas and suggestions for improvement
Prior Experience & Qualifications:
- Degree in Law, Life Sciences or Science as a minimum. Postgraduate degree is also desirable
- Minimum of 3-4 years experience in Medical Device compliance and regulatory environment
- Significant knowledge of global medical device regulations covering areas such as safety & efficacy, conformity assessment, technical documentation; labeling; record keeping, packaging; mandatory unique device identification (UDI) mechanisms, registration, etc.
- Experienced researcher
- Excellent written and oral communication skills
- Excellent project and time management skills
- Proficient in the use of computers
- Fluent in English. Additional language skills preferred, but not essential
- The successful candidate will be a hard working, self-motivated, strong communicator with good problem solving skills, initiative and attention to detail
Compliance & Risks will launch its Medical Devices topic in 2021 with the aim of helping clients to ensure that the medical devices they bring to market are safe and compliant by providing up-to-date global coverage of laws and regulations, proposed, enacted and amended, as well as relevant standards, guidance documents, factsheets and more impacting the placing on the market of medical devices.
Our Medical Devices topic will encompass historic and ongoing coverage of the following regulatory aspects :
- Definition of medical devices
- Classification of medical devices
- Safety & efficacy/performance requirements
- Conformity assessment procedures
- Technical documentation
- Provision of product information
- Record keeping
- Mandatory unique device identification (UDI) mechanisms
- Requirements for qualified person
All applicants must apply using the RELEVANT LINK.