Regulatory Affairs Consultant, Medical Devices, Ireland
We are growing at a rapid pace at Acorn Regulatory. Right now, we are seeking to hire a Medical Devices Regulatory Affairs Advisor with experience in the medical devices sector to join our growing medical devices team.
At the moment, the team is working on countless fascinating projects for clients all over the world. This role offers the opportunity to work remotely for the right candidate. Acorn Regulatory has a track record of enabling its staff members to develop their careers while working remotely.
We are regarded as one of the most dynamic regulatory consultancy firms in Europe and we work with some of the biggest names in medical devices, pharmaceutical, and clinical trials on a daily basis. We want to talk to you if you have 3/4 years experience in a regulatory role in a medical devices environment.
Essential skills / Qualifications Required:
- BSc. Minimum or Pharmacy primary degree.
- Minimum of 3/4 years experience within Regulatory Affairs or Compliance in a Medical Device Environment
- Be an authority on EU Medical Device Directives and be able to provide support as necessary
- Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.
- Excellent written and oral communication
- Ability to project manage across a diverse and complex portfolio of products and
- Ability to get on with people, to influence people both internally and externally and to achieve
- Attention to detail and solid interpersonal, communication and organisational skills
PURPOSE / KEY RESPONSIBILITIES:
- Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes.
- Review of clinical literature and preparation of Clinical Evaluation Reports.
- Preparation of Technical documentation for C.E.
- Assessment of product complaints to determine vigilance responsibility according to guidelines.
- Builds and maintains strong relationships with EU Health Authorities as appropriate to ensure ease of access.
- Works collaboratively with other department colleagues to share best practice and information
- Management / review of Non-conformances
- Preparation of Annual Product Reviews and generate documents as necessary for management review
If you are interested in this role as a Medical Devices Regulatory Affairs Advisor then please send an up to date CV to Brian Cleary at Acorn Regulatory. Email Brian at firstname.lastname@example.org . Alternately, if you would like to have an initial chat about how you could develop your career with us at Acorn Regulatory give him a call on 052 61 76706.