Seeking Regulatory Affairs Consultants
Seeking Regulatory Affairs Consultants
Tired of being bound to your desk at the office? Spending too much of your valuable ‘down time’ commuting to work?
The COVID-19 Pandemic has changed how many businesses view the workplace and working hours. At Med-Di-Dia, however, we have always been forward-thinking. From the outset, it has been the norm for us to offer ‘working from home’ and flexible hours.
Are you more productive working from home and would prefer to be assessed on deliverables rather than a rigid structure of fixed working hours? Yes? Good! Med-Di-Dia is offering you the opportunity to embrace a new way of working and regain the ‘Yin-Yang’ in your life.
If you have a ‘can do’ attitude, have proven ability to effectively manage your own time, are used to managing multiple clients and/or projects, consistently meet deadlines and have at least four years’ of professional experience in regulatory affairs relating to medical devices and/or in-vitro diagnostics (inc. Software as a Medical Device – SaMD), please send Greer (email@example.com) your CV and a covering note explaining why you want to join Med-Di-Dia and embrace the role of a MedTech Consultant.
To help you decide on whether or not you want to explore this opportunity further, please read on.
Med-Di-Dia is a regulatory affairs and quality compliance consultancy focusing on guiding, advising, and supporting Medical, Digital Health, Diagnostic, Wellness, Health and Beauty companies across Europe and the UK. From our Galway HQ, we provide a full range of Regulatory Affairs and Quality Compliance consultancy services to both local and international clients with the full support and guidance of the parent company, Global Regulatory Services (GRS).
We are on a mission to be the leading Medical Technology Regulatory Affairs and Quality Compliance Consultancy in Europe. Our key goal is to be the ‘go to’ consultancy. We are determined to cut through the maze of regulations and be a risk partner in the journey to the market never forgetting that, at journey’s end, patients will be the beneficiaries.
Med-Di-Dia is a dynamic company with an adaptable and flexible approach to our clients and their projects. Invariably this means that we attract many University and Multinational spin-outs, start-ups, and SMEs by getting involved at the design stage and assessing innovative technology to determine classification and regulatory pathways to market. Currently, a large proportion of our work is strategic, helping companies to map out scale-up and commercialisation activities in order to present this information as part of their business plan to potential investors. Of course, as part of this scale-up, all companies need a good Quality Management System in order to support their future success.
Med-Di-Dia is also acting as the EU Authorised Representative (EUAR) and Person Responsible for Regulatory Compliance (PRRC) for an increasing number of MedTech companies.
Our consultants are not only specialists but are also professionals with the ability to work on multiple projects simultaneously with no two days being the same. If you like variety and the opportunity to talk to potential new clients about their innovative technology in order to scope out how you and Med-Di-Dia can support them in achieving their goals, then you are definitely well on the road to being a consultant and we want to hear from you.
The directors are warm and welcoming with an emphasis on community, family, support, and education. They provide a friendly and safe environment for consultant staff to grow and develop in areas of the business that interest them most. They encourage individual contribution and through training, career opportunities, personal and professional development, they allow everyone the opportunity to learn, become experts and prosper.
Med-Di-Dia employees will have full and comprehensive support from the parent company, GRS’s, worldwide network of regulatory and quality compliance specialists.
Make Med-Di-Dia’s success, your success
For the right candidate, we’d love you to become an integral member of our team, helping us to continue to lay down solid foundations, to grow and develop a successful, sought after 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.
In return, we can offer a competitive salary/package with flexible working hours and a choice of working from home, in our Galway office or a hybrid of office/home working whichever is the preference of the successful candidate. There will be some travel to conferences, networking events and company meetings.
Role & Responsibilities
Ongoing and routine services
- Help clients to classify their technology and develop their regulatory strategy
- Expertise to ensure a 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)
Med-Di-Dia’s legally responsible services
- For micro and small companies, we act as the Person Responsible for Regulatory Compliance (PRRC) under the new EU Medical Device and In-Vitro Diagnostic Regulations
- For non-EU and UK companies, we function as the Authorised Representative within Europe
- For UK organisations running EU-wide clinical trials, we are the Legal Representative to ensure continuity of company trials post-Brexit
- For non-EU Health and Beauty manufacturers, we are their EU Responsible Person
Your role will be to:
- Help develop and maintain all Med-Di-Dia policies and procedures
- Create and maintain a positive working relationship with clients to facilitate efficient accomplishment of regulatory goals
- Respond to queries from all clients and prospective clients
- Provide services to clients with guidance and support from the parent company, GRS, including liaison with regulatory authorities as and when necessary
- Conducting due diligence to bring all clients into full compliance with the appropriate regulations and guidelines
- Actively participate in 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
- Promoting Med-Di-Dia through networking, workshops, and presentations
- Liaise with and engage support of management on all leads and activity
Our best people
- Third level qualification in a related discipline and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, or
- 4 years+ professional experience in regulatory affairs or in quality management systems relating to Medical Devices or Diagnostics (with exposure to Pharma a bonus)
- 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 will be a bonus
- Good problem-solving skills a must. Familiarity with international standards and regulations related to medical device or diagnostic development a plus
- Excellent 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
- Experience writing clinical evaluations and risk management reports a plus
- Knowledge of ISO 13485 and other quality systems
- Knowledge and experience of auditing quality systems a bonus
- 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
- Good communication and influencing skills, with excellent written English
- Strength of character, knowledge, and confidence to be able to inform clients 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
Still interested in joining Med-Di-Dia? Fantastic! Please send Greer (firstname.lastname@example.org) your CV with a covering note explaining why you’d like to embrace the role of a MedTech Consultant. If you’d love to have the chance to join us but you don’t believe you quite tick everything on our wish list, please apply anyway. If you have the personality and positive attitude that we’re seeking but perhaps not the full set of skills we’re asking for, then we will be happy to train and develop you to become an experienced and confident member of our team.
Alternatively, Apply via our LinkedIn Page
For successful applicants, interviews will be held from Monday 23 May 2022 onwards at a time which suits you (evenings and weekends included). Please be aware that interviews will be held via video conferencing so you’ll need good internet connection!