Regulatory Affairs Consultant (Medical Technology including medical devices, diagnostics and digital health)

Make Med-Di-Dia’s success, your success

For the right candidate, we’d love you to become an integral member of our MedTech consultancy team, helping us to continue to lay down solid foundations, to grow and develop a successful, sought after Medical Device, Digital Health and Diagnostic regulatory affairs consultancy. We will provide you with the opportunity to expand the breadth as well as depth of your knowledge with respect to devices, in-vitro diagnostics, combo products (device-drug delivery), quality management systems, software/mobile apps, digital health, robotics, fitness/wellness products and more.

Ideally, you will have 2-5 years experience in regulatory affairs and/or quality managements systems relating to Medical Devices, Diagnostics and/or Digital Health.  This is a forward-facing, fast-paced role where, in brief, you will:

• Create and maintain a positive working relationship with MedTech clients to facilitate efficient accomplishment of their regulatory goals
• Help to respond to queries from all clients and prospective clients
• Provide services to clients with guidance and support from the parent company, Global Regulatory Services Ltd (if needed), including liaison with regulatory authorities as and when necessary
• Conduct due diligence to bring all MedTech clients into full compliance with the appropriate regulations and guidelines
• Actively participate in internal and external project teams, as required
• Maintain current knowledge of regulations, standards, and guidance documents by gathering, monitoring, and analysing regulatory information and data to track developments in the changing regulatory environment to maintain Subject Matter Expert status
• Promote Med-Di-Dia through networking, workshops, and presentations etc
• Liaise with and engage support of management on all leads and activity

Role & Responsibilities

• Act as an Ambassador for the Company
• Help clients to classify their technology and develop their regulatory strategy (EU, UK, US and RoW), a particular challenge if a ‘borderline’ device
• Expertise to ensure successful EU CE Mark and/or UK CA Mark registration
• Advice, guidance, and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
• Supporting clients to transition from EU MDD to EU MDR
• Represent clients to the Regulators, as and when necessary
• Review, advise and/or compile Technical Files
• Support to create, implement and maintain compliant Quality Management Systems (QMS)
• Help develop and maintain all internal company policies and procedures

Promotional activities

• Attend conferences and networking events as an Ambassador for the company
• Deliver presentations (face-to-face or online) for training purposes or to raise the profile of the company
• Support the Marketing Department in the creation of educational blogs and posts and any other promotional literature, as and when required

Our best people

• Enjoy juggling multiple projects and supporting clients through the maze of challenges along the journey towards regulatory compliance
• Embrace variety, are flexible and adaptable – no two days are the same!
• Have a ‘can do’ attitude where no job is too big or too small
• Are happy to ‘muck in’ for the reward of completing projects on time so that innovative devices can be commercialised for the benefit of patients and clinicians
• Are able to combine knowledge of scientific, regulatory and business issues to ensure compliance with evolving regulatory requirements
• Effectively and accurately write and edit technical documents
• Bachelor’s degree in science, engineering or medical fields
• At least 5 years' experience in regulatory affairs relating to Medical Devices, Diagnostics and/or Digital Health
• Good problem-solving skills a must
• Good working knowledge of European medical device or diagnostic regulatory requirements
• Familiar with medical device technical files and all inputs, including biocompatibility, shelf life, bench testing, etc
• Knowledge of ISO 13485 and other quality systems
• Ability to self-manage multiple projects, workload, and timelines in order to consistently meet deadlines
• Remote working means being able to work on your own but must also maintain awareness of the needs and objectives of the Team and, therefore, must be able to work effectively and proactively in cross-functional teams
• Clear and effective verbal and written communication skills with diverse audiences and personnel
• Strength of character, knowledge, and confidence to be able to inform clients, with diplomacy and respect, what they need to do rather than what they want to do
• Good listener with mutual respect for colleagues and clients
• Logical approach to work, views problems as challenges, calm under pressure

• Experience of conducting internal audits for clients and provide support throughout formal audits by the Regulators
• Expertise with Software as a Medical Device (SaMD) and IEC 62304
• Software development experience including Agile and traditional development methodologies as well as embedded software and PC/Mobile applications 
• Pharmaceutical and/or Device-Drug combination products
• Experience writing clinical evaluations and risk management reports 
• Knowledge and experience of auditing quality systems 

Standard benefits package will be provided during the 6-month probationary period which includes:

• 20 days Annual Leave, home-working with provision of all IT equipment necessary to support your role ;
• a daily tax-free working from home allowance for each full day worked at home ('home' must be in Ireland). This allowance is in line with current Irish Government guidance;
• full regulatory affairs training consisting of a combination of formal training and on-the-job training provided by leading MedTech specialist; career development, enhanced and supported by the Company on the basis that it is of value to both the candidate and the company;
• Membership to The Organisation for Professionals in Regulatory Affairs (TOPRA) (and to Team-PRRC, if certain criteria met) is provided on engagement;
• financial support with visa applications to live and work in Ireland can be provided although this will be considered on a case-by-case basis.

An enhanced benefits package will be considered on successful completion of 6-month probationary period.

Company devices are provided and a virtual ergonomic/health & safety assessment of the home workstation will be undertaken.  Any additional equipment needed to ensure a safe and healthy home working environment will be provided by the Company.

The candidate must be prepared to live and work in Ireland.