Raqa (Regulatory Affairs and Quality Assurance)

Vor 4 Tagen

Basel, Schweiz Healios Vollzeit

**Your mission**:
We are committed to transforming healthcare and clinical research by harnessing the power of Digital Biomarker technology. Specializing in the development of innovative software as medical devices, we strive to revolutionize patient outcomes and elevate the standard of healthcare delivery.

As our RAQA (Regulatory Affairs and Quality Assurance) Leader, your mission is to play a pivotal role in ensuring the highest standards of quality, safety, and compliance across our groundbreaking medical software solutions.

You will lead the charge in continually improving a robust Quality Management System (QMS) that aligns with global regulatory requirements. Your expertise will drive the development and implementation of regulatory strategies, ensuring our products meet and exceed the stringent standards set by international health authorities.

**Your profile**:
As our RAQA (Regulatory Affairs and Quality Assurance) Leader, your primary responsibility is to oversee regulatory compliance and quality assurance throughout the product lifecycle. Your role is crucial in ensuring that our software as medical devices meets stringent regulatory standards while maintaining the highest quality standards.

**Quality Assurance**:

- Act as Management Representative for the ISO13485 QMS.
- Responsible for implementation, governance, performance reporting and maintenance of the company’s quality management system.
- Ensure compliance with 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.
- Responsible for complaint handling system setup, management and linkage to Change Management, reporting and management of Non-Conformities and resulting CAPAs.
- 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 with all relevant regulations, rules, and standards for products and takes part in the conformity assessment procedures with the coordination of all concerned departments.
- Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, and revising already existing technical documentation.
- 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 the integration of common tools and techniques.
- Present to internal and external audiences, including board or investors.

**Expertise and Problem-Solving Duties**:

- 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, select the specific action plans that will best meet the identified regulatory objectives.
- Be part of the vision and translate the vision to project goals, roadmap, and plans.
- Analyze risks, suggest mitigation plans, and develop alternatives to solutions.
- Proactively anticipate and identify risk areas, and alert stakeholders appropriately.

**Necessary Competence (education/qualification)**:

- An Excellent team player in a multicultural environment.
- Shows a “Can-do-attitude” with agility.
- Has passion for medical devices, digital health solutions, and an ingrained focus on quality
- Self-starter with ability to work independently under pressure and react quickly to changing priorities.
- Able to identify and assess business risks for a given regulatory strategy
- Comfortable with decision process and decision making.
- Maste

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