76 jobs in Miscellaneous (other jobs) in Geneve

Page 1 out of 4Next
Kylane Laboratoires SA

Quality Assurance and Regulatory Affairs Manager

 — Plan-les-Ouates
17 October | Executive po­si­tion | 100%

Ref jobup.ch: 1939093 | Date: 17 October 2021

Kylane Laboratoires SA

Quality Assurance and Regulatory Affairs Manager

Born of extensive experience and profound understanding of Hyaluronic Acid (HA), KYLANE LABORATOIRES is an innovation-driven biomedical company in the fast-evolving field of Aesthetic Medicine. Based in Geneva, Switzerland, KYLANE LABORATOIRES offers innovative HA solutions (injectable medical devices – class 3) used by Healthcare Professionals to enhance the well-being and beauty of women and men.

In the context of very exciting development and dynamic growth, we are looking for our Quality Assurance / Regulatory Affairs Manager.

We offer a dynamic team and an exciting, fast-paced and international work environment in the medical device industry.

Duties and Responsibilities

The primary responsibility of the position is to conduct quality assurance activities, regulatory activities and key processes of medical device lifecycle management, such as post-market surveillance and clinical evaluation.

  • Write, review and approve quality assurances deliverables (e.g. procedures, instructions, minutes, gap assessments) and related data bases (e.g. training, CAPA, supplier lists) to ensure ISO 13485 compliance
  • Manage internal and external audits program and execution in a timely manner.
  • Manage the CAPAs, change control and deviation processes (workflow, approval, meetings with the concerned functions and follow-up).
  • Coordinate quality assurance activities with crucial suppliers to collect the deliverable fulfilling ISO13485 requirements.
  • Perform batch release for medical device products.
  • Liaise with notified bodies, competent authorities and regulatory agencies regarding submissions and follow-up of submissions under review.
  • Maintain certificates as necessary to obtain and sustain product approval.
  • Provide regulatory guidance on the creation and update of the technical files and support the transition from MDD to MDR.
  • Provide guidance to product development teams regarding specific local product submission requirements in a timely manner.
  • Compile appropriate technical documents and prepare materials for local regulatory submissions.
  • Communicate with customers to respond to regulatory concerns/questions.
  • Review proposed labelling changes to determine regulatory impact on existing certifications and registration and advise R&D team and manufacturing on regulatory and labelling requirements.
  • Perform systematic literature reviews and data base searches and create related documents.
  • Critically assess and evaluate clinical data related to Kylane’s products and the clinical state of the art.
  • Collect, analyse and evaluate post-market surveillance data and ensure information exchange between stakeholders.
  • Compile information and analysis of vigilance activities for periodic reports.
  • Conduct vigilance reports and ensure reports are submitted to regulatory agencies or partners within required timelines.
  • Define safety measures (FSCA), actively participate in product recalls and recall communications to markets and health authorities as required.
  • Keep up to date with regulatory and normative requirements and ensuring their implementation in day-to-day business.
  • Extend and maintain the knowledge on existing and emerging international and local regulations, standards, or guidance documents.
  • Analyze product complaints and make recommendations regarding their reportability.

 

Profile

• Degree in life science and at least 5 years of relevant work experience in the medical device industry

• Good understanding of the regulatory framework of medical device registrations in the EU and (e.g., MDR (EU) 2017/745, ISO 13485, ISO 14971, ISO 10993)

• Proficient in systematic literature searches and data base searches using e.g. PubMed

• Experience in performing clinical evaluation of medical devices (class IIa or higher) conform with MEDDEV 2.7/1 Rev.4 is preferred

• Proactive, structured and meticulous way of working

• Strong attention to detail, analytical abilities and organizational skills required

• Proficient computer skills and at ease with Word, Excel, PowerPoint etc.

• Excellent communication skills with ability to establish relationships with co-workers and other partners

• Very good command of written and spoken English

• 100% or 80% full-time-equivalent

• Apply with your resume