Are you a safety expert with a passion for ensuring compliance and patient safety in the medical device industry? Join our esteemed client, a leading Medical Company based in the innovative city of Denver, CO, as a Medical Device Safety Manager. We are seeking a driven leader to oversee safety protocols and ensure that all medical devices meet the highest standards of safety and regulatory compliance.
About Our Client:
Our client is a forward-thinking medical company that is at the forefront of advancing healthcare through cutting-edge medical devices. With a deep commitment to quality and patient safety, they are shaping the future of healthcare solutions. As their operations expand, they are searching for a dedicated Medical Device Safety Manager to lead safety initiatives and maintain regulatory excellence.
Responsibilities of Medical Device Safety Manager:
As the Medical Device Safety Manager, you will be responsible for:
- Safety Compliance: Ensuring all medical devices meet regulatory safety requirements and adhere to industry standards such as FDA and ISO.
- Risk Management: Conducting risk assessments, analyzing safety data, and implementing strategies to mitigate potential safety hazards.
- Incident Investigation: Leading investigations into safety incidents, identifying root causes, and overseeing corrective actions to prevent future occurrences.
- Regulatory Reporting: Managing the reporting of adverse events and safety data to regulatory authorities, ensuring compliance with timelines and requirements.
- Collaboration: Working closely with R&D, quality assurance, and production teams to integrate safety practices into product development and manufacturing.
- Training & Development: Developing and delivering safety training programs to ensure all employees understand safety protocols and maintain compliance.
Qualifications:
To succeed in the role of Medical Device Safety Manager, you should possess:
- Industry Experience: Extensive experience in medical device safety management or a related field within the healthcare or medical device industries.
- Regulatory Knowledge: In-depth understanding of FDA, ISO, and other regulatory requirements pertaining to medical device safety.
- Leadership Skills: Proven ability to lead safety initiatives, manage teams, and drive a safety-first culture across the organization.
- Analytical Mindset: Strong analytical skills with the ability to assess risks, interpret safety data, and recommend actionable improvements.
- Educational Background: A bachelor’s degree in a related field such as Biomedical Engineering, Regulatory Affairs, or Quality Assurance is required; advanced certifications in safety or regulatory compliance are highly desirable.
How to Apply:
If you are a dedicated safety professional ready to lead in the medical device industry, we encourage you to submit your resume and a cover letter outlining your qualifications and vision for the role. Be part of a leading company that is dedicated to safety and innovation in healthcare.
Looking for more roles in the medical device industry? Explore our Expert Medical Device Executive Recruitment page for more exciting opportunities!
