Quality & Regulatory Manager
Quality & Regulatory Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Main Purpose of Role
- To centrally manage a Lean and compliant Quality Management system for medical devices schemes (Medical includes Notified Body NB1639 UKCA ISO 13485 MDSAP and all other Medical Schemes at SGS)
- Management of external audits and communication with competent authority
- Management of internal audits and communication with relevant departments
- Maintaining designation under MDR/IVDR and support the development and designation under new schemes
- Maintaining accreditation under MDSAP ISO 13485 and UKCA and support the development of other new schemes
- Coordinate all activities with auditing organisations ( Belgian and English competent authority UKAS .)
- Coordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers
This role will report to the Head of Certification and Compliance Business Assurance.
It is remote based and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.
Key Accountabilities
- Own and oversee all medical devices processes including the Quality Manual Non-Conformity and CAPA handling audits and inspections document and records control internal audits quality management reviews concessions and impartiality.
- Supervise the implementation and maintenance of the medical quality management system (QMS) ensuring alignment with global processes and accreditation requirements.
- Ensure impartiality and independence from commercial interests including conducting annual risk analyses.
- Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR ISO 13485 MDSAP and other relevant schemes.
- Lead internal and external audits and ensure timely closure of CAPAs.
- Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions.
- Write and revise QA-related procedures and associated documentation.
- Continuously optimise the QMS to improve turnaround times while maintaining compliance.
- Make decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives.
- Compile and analyse data for management review reporting.
- Manage all regulatory processes to ensure full compliance across all Medical Schemes.
- Ensure all contractual agreements including those with inter-office and subcontractors are current compliant and properly maintained.
- Responsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities applicable legislation guidance and best practices.
- Planand implement relevant regulatory training programs in collaboration with training team .
- Ensure the SGS Medical website remains current and accurate in terms of regulatory content.
- Build strong working relationships with global medical device teams and proactively work on projects with stakeholders
- Provide technical support and training across the business when required
- Manage and develop the Quality & regulatory team including performance management coaching and staff development.
Skills & Knowledge
Essential
- Strong knowledge of Medical Device Regulations (MDD MDR IVDR) and ISO13485 ISO17021 and MDSAP
- Strong ability to work with senior management technical marketing sales and administrative personnel at a corporate regional and delivering office level
- Ability to represent SGS to medical device regulatory authorities and other external fora
- Excellent interpersonal and communication skills including fluency in English
- Negotiation and persuasion skills
- Change Management skills
- Strong organisational skills and flexibilty
- 5 years experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization (a must have).
- 2 year experience in team management (must have)
- Has at least 10 years experience of either working in a Health Science related industry in Design Manufacturing or Quality and Regulatory functions or previous experience with either Management System registrars Notified Bodies or Testing laboratories or Industry
- Has a keen eye for detail and is focussed on delivering results within agreed timeframes
- Operates ethically with the highest degree of professional integrity
Qualifications :
Essential
- Higher education qualification (Masters / Ph.D. / . (Hons) Degree) in a relevant life / natural sciences subject.
- Completed Medical device training on MDD MDR IVDR UKCA MDSAP and ISO 13485
Please send your CV in English
Additional Information :
Why SGS
- Global and very stable company world leader in the TIC (Testing Inspection and Certification) industry.
- Flexible schedule and hybrid model.
- SGS university and Campus for continuos learning options.
- Multinational environment where you will work with colleagues from multiple continents.
- Benefits platform.
Join Us: At SGS we believe in innovation collaboration and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
Company Industry
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
