OiO.lk Community platform!

Oio.lk is an excellent forum for developers, providing a wide range of resources, discussions, and support for those in the developer community. Join oio.lk today to connect with like-minded professionals, share insights, and stay updated on the latest trends and technologies in the development field.
  You need to log in or register to access the solved answers to this problem.
  • You have reached the maximum number of guest views allowed
  • Please register below to remove this limitation

Director of Quality and Regulatory Affairs

  • Thread starter Thread starter Rss
  • Start date Start date
R

Rss

Guest
Cleveland, Ohio Dynamix Group

Responsibilities



  • Quality Management:
    • Develop, implement, and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
    • Oversee internal and external audits to ensure compliance with regulatory requirements and internal policies.
    • Set and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture.
  • Regulatory Affairs:
    • Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.
    • Prepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required.
    • Monitor and interpret regulatory developments and communicate implications to the executive team.
  • Leadership and Collaboration:
    • Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
    • Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.
    • Serve as the primary point of contact with regulatory bodies and notified bodies, managing all communications and inspections.
  • Training and Education:
    • Develop and conduct training programs on quality and regulatory requirements for employees.
    • Ensure all staff are informed about the latest regulatory changes and quality standards.
    • Additional duties as assigned.



Requirements



A Bachelor’s degree required.


  • 15 + years of Quality experience.
  • A strong history of leadership skills with the ability to hire, mentor and guide Quality Engineering professionals.
  • The successful candidate will come from the Medical Devices industry.
  • Lean, Six Sigma, ASQ or similar certification beneficial.
  • Experience with new product development and approval with original product submissions (CE Mark and FDA 510(k)).
  • Experience with maintaining medical device quality systems and complaints, specifically ISO 13485.
Cleveland, Ohio
Dynamix Group<br/>
<p><strong><span style="color:inherit; font-family:inherit; font-size:10pt">Responsibilities</span></strong></p>
<p><strong><span style="color:inherit; font-family:inherit; font-size:10pt"> </span></strong></p>
<ul><li><span style="color:inherit; font-family:inherit; font-size:10pt">Quality Management:</span>
<ul><li><span style="color:inherit; font-family:inherit; font-size:10pt"><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Develop, implement, and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.</span></span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Oversee internal and external audits to ensure compliance with regulatory requirements and internal policies.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Set and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture.</span></li></ul></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">Regulatory Affairs:</span><ul><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Prepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Monitor and interpret regulatory developments and communicate implications to the executive team.</span></li></ul></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">Leadership and Collaboration:</span><ul><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Serve as the primary point of contact with regulatory bodies and notified bodies, managing all communications and inspections.</span></li></ul></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">Training and Education:</span><ul><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Develop and conduct training programs on quality and regulatory requirements for employees.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Ensure all staff are informed about the latest regulatory changes and quality standards.</span></li><li><span style="color:inherit; font-family:times new roman,serif; font-size:10pt">Additional duties as assigned.</span></li></ul></li></ul>
<p><span style="color:inherit; font-family:times new roman,serif; font-size:10pt"> </span></p>
<p><strong><span style="color:inherit; font-family:inherit; font-size:10pt">Requirements</span></strong></p>
<p><span style="color:inherit; font-family:inherit; font-size:10pt"> </span></p>
<p><span style="color:inherit; font-family:inherit; font-size:10pt">A Bachelor’s degree required.</span></p>
<ul><li><span style="color:inherit; font-family:inherit; font-size:10pt">15 + years of Quality experience.</span></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">A strong history of leadership skills with the ability to hire, mentor and guide Quality Engineering professionals.</span></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">The successful candidate will come from the Medical Devices industry.</span></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">Lean, Six Sigma, ASQ or similar certification beneficial.</span></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">Experience with new product development and approval with original product submissions (CE Mark and FDA 510(k)).</span></li><li><span style="color:inherit; font-family:inherit; font-size:10pt">Experience with maintaining medical device quality systems and complaints, specifically ISO 13485.</span></li></ul>
 

Latest posts

S
Replies
0
Views
1
Safwan Aipuram
S
Top