Post Market Quality, Regulatory and Vigilance Senior Specialist

Job title:

Post Market Quality, Regulatory and Vigilance Senior Specialist

Company:

Dedalus

Job description

Do you want a job with a purpose?And do you want to make healthcare safer, better and more reliable?Join our Team!As Quality and Regulatory Professional and member of an international team you will ensure quality, regulatory compliance, and safety and efficacy of our medical devices and non-medical products.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

Expected salary

Location

Málaga

Job date

Fri, 26 Apr 2024 22:46:03 GMT

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