Director of Regulatory Affairs
Remington Medical is an Atlanta based medical device manufacturer, providing medical products to doctor's offices and hospitals.
We manufacture our own Remington-branded products as well as products for several contract manufacturing customers.
We are seeking a Director of Regulatory Affairs who will be responsible for maintaining regulatory compliance.
This person will be an integral part of our leadership team and will collaborate with other departments to achieve our Company goals.
Key
Responsibilities:
Reports to company top management (President or CEO, as applicable) Ensure all relevant quality and regulatory requirements are met for product/processes along with compliance to federal and international regulatory requirements (i.
e.
FDA QSRs, ISO 13485, EU MDRs, CMDR, other international requirements) Serve as Management Representative and Host for FDA and other 3rd party audits/inspections Serve as Person Responsible for Regulatory Compliance (EU designation under EU MDR 2017/745) Responsible for ensuring the conformity of devices is appropriately checked before release, in accordance with the quality management system Responsible for the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date Responsible for the post-market surveillance obligations are complied with in accordance with EU MDR 2017/745 Article 10(10) Responsible for the reporting obligations referred to in EU MDR 2017/745 Articles 87 to 91 are fulfilled Responsible for in the case of investigational devices, the statement referred to in EU MDR 2017/745 Section 4.
1 of Chapter II of Annex XV is issued Prepare and review FDA submissions and other regulatory documents including 510(k)s.
Lead regulatory efforts required to align with new regulations and requirements including changes to international standards.
Interpret Regulatory Authority policies and guidance and integrate them as appropriate in product development, quality, and regulatory activities.
Advanced degree in engineering or science required complex operations or manufacturing environment Qualified Candidate Requirements:
Bachelors Degree in Engineering or Technical sciences required (e.
g.
law, medicine, pharmacy, engineering or another relevant scientific discipline) Masters Degree in Engineering or other related field preferred, or education/experience equivalency 6
years of related management experience in medical device or FDA regulated industry High level of competency is FDA QSRs, ISO 13485 and other national and international requirements Demonstrated ability to organize and motivate cross-functional teams in a multi-site company to achieve quality goals Demonstrated ability to communicate and work effectively as a team member and colleague within functional team processes such as MRB and design reviews Excellent communication, prioritization and organizational skills with experience communicating quality metrics directives to senior management and company staff Current passport required Other Desired Training, Skills, and Certifications:
Certified Quality Engineer (CQE) or other relevant ASQ certification preferred Regulatory Affairs Certification (RAC) or other relevant RAPS certification preferred Green Belt or Black Belt certification preferred Knowledge and application of Six Sigma methods preferred Knowledge and application of Lean Manufacturing methods preferred General understanding of national and international requirements for marketing medical devices PI226235104 Recommended Skills Auditing Communication Coordinating Hardworking And Dedicated Iso 13485 Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
We manufacture our own Remington-branded products as well as products for several contract manufacturing customers.
We are seeking a Director of Regulatory Affairs who will be responsible for maintaining regulatory compliance.
This person will be an integral part of our leadership team and will collaborate with other departments to achieve our Company goals.
Key
Responsibilities:
Reports to company top management (President or CEO, as applicable) Ensure all relevant quality and regulatory requirements are met for product/processes along with compliance to federal and international regulatory requirements (i.
e.
FDA QSRs, ISO 13485, EU MDRs, CMDR, other international requirements) Serve as Management Representative and Host for FDA and other 3rd party audits/inspections Serve as Person Responsible for Regulatory Compliance (EU designation under EU MDR 2017/745) Responsible for ensuring the conformity of devices is appropriately checked before release, in accordance with the quality management system Responsible for the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date Responsible for the post-market surveillance obligations are complied with in accordance with EU MDR 2017/745 Article 10(10) Responsible for the reporting obligations referred to in EU MDR 2017/745 Articles 87 to 91 are fulfilled Responsible for in the case of investigational devices, the statement referred to in EU MDR 2017/745 Section 4.
1 of Chapter II of Annex XV is issued Prepare and review FDA submissions and other regulatory documents including 510(k)s.
Lead regulatory efforts required to align with new regulations and requirements including changes to international standards.
Interpret Regulatory Authority policies and guidance and integrate them as appropriate in product development, quality, and regulatory activities.
Advanced degree in engineering or science required complex operations or manufacturing environment Qualified Candidate Requirements:
Bachelors Degree in Engineering or Technical sciences required (e.
g.
law, medicine, pharmacy, engineering or another relevant scientific discipline) Masters Degree in Engineering or other related field preferred, or education/experience equivalency 6
years of related management experience in medical device or FDA regulated industry High level of competency is FDA QSRs, ISO 13485 and other national and international requirements Demonstrated ability to organize and motivate cross-functional teams in a multi-site company to achieve quality goals Demonstrated ability to communicate and work effectively as a team member and colleague within functional team processes such as MRB and design reviews Excellent communication, prioritization and organizational skills with experience communicating quality metrics directives to senior management and company staff Current passport required Other Desired Training, Skills, and Certifications:
Certified Quality Engineer (CQE) or other relevant ASQ certification preferred Regulatory Affairs Certification (RAC) or other relevant RAPS certification preferred Green Belt or Black Belt certification preferred Knowledge and application of Six Sigma methods preferred Knowledge and application of Lean Manufacturing methods preferred General understanding of national and international requirements for marketing medical devices PI226235104 Recommended Skills Auditing Communication Coordinating Hardworking And Dedicated Iso 13485 Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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