Regulatory Affairs Manager
Meet Life Sciences, Bracknell, Bracknell Forest
Regulatory Affairs Manager
Salary not available. View on company website.
Meet Life Sciences, Bracknell, Bracknell Forest
- Full time
- Permanent
- Onsite working
Posted 1 week ago, 15 Jul | Get your application in now before you miss out!
Closing date: Closing date not specified
job Ref: bf7c30626f4043fd9612bda82f382774
Full Job Description
Regulatory Compliance and Quality Assurance:
Ensure compliance with EU MDR 2017/745, FDA QSR, ISO 13485, and ISO 14971 standards.
Oversee the maintenance and improvement of the Quality Management System (QMS).
Lead activities related to regulatory submissions, including technical file preparation and updates.
Act as the primary point of contact for regulatory inspections and audits.
Provide guidance on risk management processes in line with ISO 14971 to ensure patient safety.
Monitor changes in regulations and implement necessary updates to processes and documentation.
Quality Systems Development:
Develop and maintain quality engineering methodologies to ensure product compliance.
Support post-market surveillance activities, including adverse event reporting and vigilance.
Lead internal and supplier audits, ensuring effective corrective and preventive actions (CAPA).
Collaborate with cross-functional teams to ensure compliance throughout the product lifecycle.
Measure and improve the quality of internal and external components and suppliers.
Project Support:
Support design and development teams with quality and regulatory guidance.
Ensure proper execution of design control and validation activities for new and existing products.
Provide input on usability and human factors engineering to meet regulatory expectations.
Lead the creation and implementation of post-market surveillance plans.
Bachelor's degree in Engineering, Quality Assurance, Regulatory Affairs, or a related field.
5+ years of experience in a QA/RA role within the medical device industry.
In-depth knowledge of EU MDR, ISO 13485, ISO 14971, and related regulatory standards.
Proven experience managing QMS in a regulated environment.
Strong understanding of risk management principles and regulatory submissions.
Excellent analytical, organizational, and communication skills.
Ability to lead and influence cross-functional teams.
Experience with regulatory inspections and audits is a plus.
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