Post Market Quality and Regulatory Professionals

hace 1 semana

España Dedalus SA A tiempo completo

Vous souhaitez donner du sens à votre métier ?

Vous voulez contribuer à l'amélioration de nos soins de santé ?

Alors rejoignez notre équipe

Your Challenge:

- Embedded in the fast growing global Quality and Regulatory Team, you ensure regulatory compliance of our post market activities, managing our Health IT software medical devices.
- You review post market risk assessments performed by the clinical teams and assess the related product issues for reportability.
- Supporting the international Product Quality teams you drive and guide the cross functional teams addressing product issues to initiate, define and implement effective preventive and corrective actions.
- You drive and ensure compliant and timely resolution of vigilance related tasks like incident and trend reporting, field safety corrective actions for all applicable regulatory agencies.
- You conduct Post Market Surveillance activities and prepare and approve formal written reports, expressing opinions on the adequacy and effectiveness of the system and activity reviewed.
- You ensure that customer and service communication is regulatory compliant and accurate Your regular trend analysis reporting on product quality in our customer base supports senior management in taking effective decision for quality improvements.
- In our fast-growing business segment, your regulatory consulting is key in continuous improvement of our business processes.

Your Profile:

- University Degree (Engineering, Computer Science or Science) or equivalent from experience
- Minimum 3-5 years’ experience in a regulated industry - preferably medical device or related - in project management, analyst, technical support, quality management, or quality assurance and regulatory affairs position
- Familiar with international regulations and standards pertaining to medical devices development and servicing; familiarity with ISO 9001, ISO 13485, ISO 14971, MDR and ability to interpret and work with regulations and standards
- Active experience in Authority Communication of incidents and field safety corrective actions.
- Exposure to risk management processes, CAPA, Vigilance Management, Post Market Surveillance and software development Team player with self-starter attitude and excellent communication, collaboration, negotiation, conflict resolution, relationship-building skills
- Strong organizational skills, the ability to meet deadlines and the ability to navigate in an environment with several quality management systems.
- Experience with regulatory requirements for After Sales Processes and writing process documentation.
- Knowledge of data analysis and statistical techniques, knowledge of R programming language is an asset.
- Very good English verbal and written language skills, knowledge of one of the following languages German, French, Italian or Dutch is an asset.
- This position offers stepwise growth with adaptive challenges based on your experiences, so junior, senior and professionals profiles are welcome

Our benefits for you:

- A major challenge in an exciting, innovative and international high-tech company
- A permanent employment contract for long-term perspective
- A competitive salary package complemented by fringe benefits
- Flexible working time, adapting to the personal needs and preferences

  • Cmc Regulatory Specialist

    hace 2 semanas

    España G&L Scientific A tiempo completo

    Please note this position can be located in our offices in Barcelona with 2 days on site. Por favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de interés. G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work –...

  • Regulatory Compliance Officer

    hace 2 semanas

    España G&L Scientific A tiempo completo

    Por favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de interés. G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance consultancy work – and we are rapidly growing! You'd be joining our international team of experienced...

  • Market Surveillance Specialist

    hace 1 semana

    españa Werfenlife SA. A tiempo completo

    Market Surveillance Specialist (Temporary position) Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Immunoassay business line, we research, develop, and...

  • Quality Assurance Specialist

    hace 2 semanas

    España Actual Talent Spain A tiempo completo

    Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through...

  • QA & Regulatory Affairs Lead - Medical Devices

    hace 2 semanas

    españa STAAR Surgical A tiempo completo

    A leading medical device company in Spain is looking for a professional to support the implementation and maintenance of their Quality Management System (QMS). Responsibilities include assisting with regulatory compliance and conducting training for staff. Candidates should have relevant education and experience, particularly in Quality Assurance and...

  • Manual Quality Assurance

    hace 1 semana

    España Golden Race A tiempo completo

    **What does our company do?**: GoldenRace is a global market leader for virtual sports betting. We are a growing team of motivated professionals from many backgrounds and disciplines, operating together in a positive and supportive environment to grow and excel as one of the most promising and rapidly expanding companies in the betting industry. Join us to...

  • Business Development Manager

    hace 2 semanas

    españa TOPTALENT A tiempo completo

    Business Development Manager (Asia Market) About the job Position : Business Development Manager (Asia Markets) Location : Remote within Thailand, Malaysia, Korea Employment type : Full-time DUTIES AND RESPONSIBILITIES Identify, recruit, and manage strategic partners, affiliates, and business introducers across target markets. Develop and implement...

  • Técnico de Laboratorio Textil

    hace 2 semanas

    España Recover A tiempo completo

    About our Company Recover™ is a leading materials science company and global producer of low-impact, high-quality recycled cotton fiber and cotton fiber blends. Our purpose We enable large-scale sustainable change in fashion through business value & inspiration. Your role purpose Assist in ensuring products and processes meet quality requirements through...

  • Customer Service

    hace 1 semana

    España Jobs Europe AB A tiempo completo

    We are seeking financial services professionals to join an international team at the world's most successful BPO organization. With more than 40 years of experience in the banking industry, a presence in 88 countries and more than 420,000 employees, Teleperformance is building a multilingual team of investment specialists. Aimed at people interested in the...

  • Costumer & Supplier Quality Engineer Quality

    hace 1 semana

    España ARaymond A tiempo completo

    Costumer & Supplier Quality Engineer**CALIDAD** **FECHA DE INICIO** Inicio inmediato**LUGAR** SANT FRUITÓS DE BAGES, España.**TIPO DE CONTRATO** Contrato indefinido**TIEMPO TRABAJADO** 40 hours/week**SOLICITAR AHORA** En ARaymond, fabricamos avanzados sistemas de unión y montaje para máquinas y productos que mantienen el mundo en...