About you
You are an ambitious and experienced QARA professional with at least 3 years of experience in quality assurance and regulatory affairs in the medical devices industry, particularly medical device design and development. You enjoy learning new things, are solution-focused and happy at the interface of technical, legal and regulatory aspects of product development.
List of primary duties and responsibilities (not exhaustive):
- Authoring and reviewing medical device technical documentation/DHF/DMR/DHR according to relevant requirements:
- UK MDR
- EU MDR (CE Marking)
- U.S. FDA (Premarket Notifications (510(k))
- Experience needed in compiling the below technical documentation including:
- Product specifications
- Labelling
- Documentation and verification of design controls
- Authoring and reviewing development and manufacturing procedures
- Collating manufacturing records
- Clinical validation protocols and reports
- Post-market surveillance and post-market clinical follow-up protocols and reports
- Compiling and updating risk management documentation (ISO 14971)
- Liaison between product development, manufacturing, QARA, marketing, HR and legal departments:
- Coordinate communication as needed to execute QARA tasks
- Remain up to date on changes to country-specific regulations, updated standards/guidance documents and industry trends.
List of secondary duties and responsibilities (not exhaustive):
- Maintain and organise the company’s QMS and ISMS including:
- Compiling new SOPs and policies, updating existing SOPs and policies as needed
- Management of change control approvals and CAPAs
- Management of supplier approvals and reviews
- Preparation and presenting information in management reviews and following up on actions
- Conducting internal audits, following up on NCs
- Participate in external regulatory and customer audits
- Conducting quality and regulatory training as needed
- May need to carry out quality system administration as needed
Qualifications:
- Bachelor’s degree in quality management, regulatory affairs or related field (medical, scientific or engineering)
Work experience:
- Minimum of 3 years experience as a quality/regulatory professional in the medical devices industry
Skills (critical):
- Experience in quality management systems (ISO 13485 / 21 CFR 820)
- Experience in compiling medical device technical documentation
- Ability to independently carry out research and summarise findings
- Strong written and verbal communication skills
- Extremely high level of attention to detail
- Flexibility to carry out various tasks within the QA department according to changing priorities
Skills (desirable):
- Experience in medical device software validation (ISO 62304)
- Experience in information security (ISO 27001)
- Experience in UK DPA, EU GDPR and HIPAA regulations
- An ISO 9001 / ISO 13485 / ISO 27001 internal/supplier/lead auditor certification will be highly advantageous
Job Reference no. QA099