Regulatory Affairs & Quality Compliance Engineer
|Job Title:||Regulatory Affairs & Quality Compliance Engineer|
|Salary:||€30 - 45k, DOE|
|Contact Name:||Brid Connolly|
Our NEW Galway based client is a regulatory affairs and quality compliance consultancy focusing on the Medical, Digital Health and Diagnostic sectors of the European Life Science Industry.
Med-Di-Dia will provide a range of Regulatory Affairs and Quality compliance consultancy to local clients, from their Galway HQ, with the full support and guidance of their parent company Global Regulatory Services (GRS).
Med-Di-Dia Ltd is on a mission to be the leading Medical Technology Regulatory Affairs and Quality Compliance Consultancy in Europe. To be the ‘go to’ consultancy. They will 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.
The Med-Di-Dia client portfolio ranges from University spin-outs, SMEs to Multinationals. Products are often cutting-edge with technology which is quite simply ‘mind blowing’.
Med-Di-Dia deal with a wide variety of projects and clients. This exciting technology exposure, means exciting work!
The directors are warm and welcoming with an emphasis on community, family, support and nurturing. 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 of their parent company GRS’s worldwide network of regulatory and quality compliance specialists.
Make Med-Di-Dia’s success, your success
Med-Di-Dia want you to become part of the company’s foundations, to grow and develop a successful, sought after consultancy. They will provide you with the opportunity to expand the breadth as well as depth of your knowledge: devices, in-vitro diagnostics, combo products (device-drug delivery), quality management systems, software/mobile apps, digital health, robotics, fitness/wellness products….
They offer a competitive salary/package with flexible working hours and a blend of office/remote working to suit their employee’s needs.
Role & Responsibilities
Med-Di-Dia services are to include:
Ongoing and routine services:
- Help clients to define their product and develop their regulatory strategy.
- Expertise to ensure a successful EU CE Mark registration.
- Advice, guidance and implementation of all mandatory standards, such as ISO 13485:2016 (Quality Management Systems)
Time critical services:
- For micro and small companies, they are the Person Responsible under the new EU Medical Device and In-Vitro Diagnostic Regulations.
- For non-EU and UK companies, they are the Authorised Representative within Europe.
- For UK organisations running EU-wide clinical trials, they act as the Legal Representative to ensure continuity of company trials post-Brexit.
Your role would be to:
- 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 local queries from all clients.
- Provide services to local clients with guidance and support of senior local specialists and at 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 and guidances by gathering, monitoring and analysing regulatory information and data to track developments in the changing regulatory environment.
- Promoting Med-Di-Dia at local level through networking, workshops and presentations.
- Liaise with and engage support of peers and management on all local 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 (with exposure to Pharma a bonus).
- Good problem-solving skills a must. Familiarity with international standards and regulations related to medical device development a plus.
- Excellent knowledge of European medical device 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.
- Team player who can work effectively and proactively in cross-functional teams.
- Competence to manage multiple projects at once and be results oriented.
- Good communication and influencing skills, with excellent written English.
- Good listener with mutual respect for colleagues and clients.
- Logical approach to work, views problems as challenges, calm under pressure.
Do you feel that you are the unsung hero in your organisation? Yes? Then Med-Di-Dia is the place for you!
Give ICE Group a call for an informal chat on 091 546700. Speak to Brid, Dean, David or Aileen
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