Integrated DNA Technologies (IDT)
Sr. Manager, Regulatory Affairs, Core and NGS
Integrated DNA Technologies (IDT), Boulder, Colorado, United States, 80301
Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Assurance and Regulatory Affairs group located in Boulder, CO or Coralville, IA, USA and will be onsite. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.
In this role, you will have the opportunity to:
Oversee and direct a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post-market surveillance activities, etc.
Author and/or review regulatory documents for submission and global market entry providing regulatory expertise to team and effective communication to Sr. Leadership to ensure robust regulatory applications and acceptability of development documentation to achieve departmental and business objectives.
Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
Provide guidance and recommendations to business teams and Sr. Leadership in consideration and impact of current or emerging regulatory issues, works with management from site to facilitate and ensure site practices are consistent with the corporate guidance and SOPs.
Support highly technical or major business segment product lines, special projects or strategic initiatives functioning as Regulatory SME/Lead; may additionally support internal and external regulatory audits.
Communicate and establish strong working relationships with cross-functional managers to problem solve, make decisions, and mediate potential team dynamics.
Other duties as assigned.
The essential requirements of the job include:
Minimum bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related required.
Knowledge and experience in global IVD regulations, quality standards and product development process such as ISO 13485, US FDA 21 Part 820, IVDR, design control, risk management, etc. required.
Minimum 10 years of experience in regulated environment required; 8+ years of global regulatory experience related to
in vitro diagnostics
required.
It would be a plus if you also possess previous experience in:
Experience in IVD software preferred.
Prior experience holding accountability and responsibility for global business metrics and application of data-based process improvements.
The salary range for this role is $117,000-$150,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Assurance and Regulatory Affairs group located in Boulder, CO or Coralville, IA, USA and will be onsite. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.
In this role, you will have the opportunity to:
Oversee and direct a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post-market surveillance activities, etc.
Author and/or review regulatory documents for submission and global market entry providing regulatory expertise to team and effective communication to Sr. Leadership to ensure robust regulatory applications and acceptability of development documentation to achieve departmental and business objectives.
Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
Provide guidance and recommendations to business teams and Sr. Leadership in consideration and impact of current or emerging regulatory issues, works with management from site to facilitate and ensure site practices are consistent with the corporate guidance and SOPs.
Support highly technical or major business segment product lines, special projects or strategic initiatives functioning as Regulatory SME/Lead; may additionally support internal and external regulatory audits.
Communicate and establish strong working relationships with cross-functional managers to problem solve, make decisions, and mediate potential team dynamics.
Other duties as assigned.
The essential requirements of the job include:
Minimum bachelor’s degree in a technical field such as chemistry, biochemistry, biology, or related required.
Knowledge and experience in global IVD regulations, quality standards and product development process such as ISO 13485, US FDA 21 Part 820, IVDR, design control, risk management, etc. required.
Minimum 10 years of experience in regulated environment required; 8+ years of global regulatory experience related to
in vitro diagnostics
required.
It would be a plus if you also possess previous experience in:
Experience in IVD software preferred.
Prior experience holding accountability and responsibility for global business metrics and application of data-based process improvements.
The salary range for this role is $117,000-$150,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
#J-18808-Ljbffr