Adresse
Form der Arbeit IT / telecommunications
- Permanent full time
- Reference : INT-028321
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Details
- Region Basel
- Type of contract Permanent full time
- Sector of activity IT / telecommunications
Introduction
For our client a growing MedTech company located in Basel / Rennes, we are looking for an individual as
Quality Assurance & Regulatory Affairs (RA/QA) Manager – MedTech
permanent employment, full time) The earliest start date is as soon as possible.
Description of the mission
Quality Assurance:
- Management Representative, responsible for implementation, governance,
- performance reporting and maintenance of the ASPIVIX's quality management
- system.
- Ensure compliance to applicable regulatory requirements (e.g., MDR, ISO
- 13485, US FDA, CFDA).
- Support R&D with development and maintenance of the technical files
- according to applicable regulatory requirements (e.g.: Risk Management as
- per ISO 14971 and Design Controls).
- Act as the liaison with external parties on matters relating to the quality system
- that include regulatory/client and third-party audits. Act as Site Management
- Representative and coordinate all audits, inclusive of schedules,
- communication, reports and tracking follow-up actions.
- Develop and maintain the internal audit process as well as suppliers' controls
- and audits.
Regulatory Affairs:
- Develops regulatory strategy for new products (Class I (s)(m)(r) and IIa) and
- implements plans to obtain FDA clearance/approvals, CE Mark and other foreign regulatory approvals.
- Manages compliance to all relevant regulations, rules and standards for products and taking part in the conformity assessment procedures with coordination of all concerned departments.
- Manages conformity assessment process and registration process for products including dossier preparation, submission to Competent Authorities or Notified Body, reviews of application and implementation.
- Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentations.
- Maintains regulatory compliance of Technical Files.
- Elaborates and reviews changes to existing Products, SOPs, Test Methods,
- Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies.
- Lead regulatory assessment of marketing claims and external communication.
- Performs staff training on the topic of regulatory affairs.
Leadership Activities:
- Foster the cooperation between diverse disciplines and functions managing a good balance between discussion, consensus, argumentation and decisiveness.
- Lead others in the completion of project tasks and sub projects
- Smooth & facilitate the decision-making process.
- Create a work environment that supports team effectiveness.
- Provide feedback to team members.
- Assist with integration of common tools and techniques.
- Present to internal and external audiences, including board or investors.
- Identify resource requirements, cost, and time schedules. Develop an implementation plan, conduct risk assessments and develop contingency plans to accommodate unforeseen events.
- As part of the management team, selects the specific action plans that will best meet the identified business objectives.
- Be part of the vision and translate vision to project goals, roadmap and plans.
- Analyze risks, suggest mitigation plans and develop alternatives to solutions.
- Proactively anticipate and identify risk areas, alert stakeholders appropriately.
- Able to identify and assess business risks for a given regulatory strategy
Required profile
- You are an Excellent team player in a multicultural environment.
- Shows a "Can-do-attitude” with agility.
- Has passion for medical device.
- Self-starter with ability to work independently under pressure and react quickly to
- changing priorities.
- You are comfortable with decision process and decision making.
- Master's degree in life science, engineering or related fields.
- Five (5) years minimum experience in regulatory affairs in MedTech.
- Five (3) years minimum experience in regulatory affairs Management in MedTech.
- You have proven track record in flawless registrations of medical devices in Europe and in
- the US. Medical device registration in APAC area is a plus
- Current knowledge of FDA 21 CFR part 820, Medical Device Regulation (MDR 2017 /
- 745), ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11137, ISO 10993
Application process:
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.
Apply !
Information
- Reference INT-028321
- Published on 11 avril 2022
- Consultant Jie Zhu
Apply !
