Staff Regulatory Affairs Specialist

Analog Devices; Valencia; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading global semiconductor firm in Valencia seeks a Staff Regulatory Affairs Specialist to improve patient care through novel monitoring solutions. Responsibilities include managing regulatory submissions, ensuring compliance with ISO standards, and working in cross-functional teams. Ideal candidates should have an MS in Regulatory Affairs and be familiar with ISO 13485 and FDA QSR. This role involves strategic regulatory guidance and quality systems management in a fast-paced environment.

Formación

• Experience with ISO 13485, MDSAP and FDA QSR.
• Willingness to learn and adapt.
• Hands-on approach in regulatory affairs.

Responsabilidades

• Provide strategic input on regulatory requirements.
• Prepare regulatory submissions and technical documents.
• Support quality-engineering methodologies.
• Manage multiple projects to meet deadlines.
• Ensure compliance with design controls.

Conocimientos

Regulatory requirements knowledge

Quality systems management

Risk management

Project management

Educación

MS in Regulatory Affairs

Herramientas

ISO 13485

FDA QSR

Descripción del empleo

About Analog Devices

Analog Devices, Inc. (NASDAQ : ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more atand onand.

Summary of the Role / About the Team & Org

ADI’s Medical Products Group is developing novel remote monitoring solutions that improve patient care and quality of life. The Medical Products Group is looking for an energetic Staff Regulatory Affairs Specialist for the development of novel solutions.

Specific Responsibilities / Duties

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering FDA regulations
• Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
• Ensure that all requirements are met for the Product Lifecycle Process, Risk Management, Design Controls, and Usability Testing
• Work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements
• Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
• Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
• Participate in negotiations and interactions with regulatory authorities during the development and review process
• Support international product registrations as needed
• Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules
• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities
• Review promotional and advertising material
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
• Participate in internal and external audits as needed
• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
• Ensure compliance with design controls in accordance with ISO 13485 standard and 21 CFR 820 regulation.
• Manage Internal Audit program in accordance with ISO 13485 and MDSAP and host all 3rd party audits including FDA.
• Provide training of QMS processes
• Perform other duties as assigned or required

Previous Experience / Skills Needed & Education Requirements

MS Regulatory Affairs

Experience with ISO 13485, MDSAP and FDA QSR

Should be willing to learn & shouldn’t be afraid of getting their hands dirty!

Job Req Type : ExperiencedRequired Travel : Yes, 10% of the timeShift Type : 1st Shift / Days