Katalyst CRO
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- Complete and maintains regulatory approvals/clearances of heart valve replacement and repair devices,
- Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting requirements and resolving moderately complex conflicts between requirements and development issues; also keeps management apprised of alternative actions.
- Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
- Work with global cross-functional teams.
- Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans.
- Prepare and oversee documentation packages for submission to global regulatory agencies.
- Track timelines and documents milestone achievements for inclusion in regulatory submissions.
- May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, China NMPA other global regulatory agencies).
- Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process.
- Complete and maintains regulatory approvals/clearances of heart valve replacement and repair devices,
- Represent the Regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting requirements and resolving moderately complex conflicts between requirements and development issues; also keeps management apprised of alternative actions.
- Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
- Work with global cross-functional teams.
- Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans.
- Prepare and oversee documentation packages for submission to global regulatory agencies.
- Track timelines and documents milestone achievements for inclusion in regulatory submissions.
- May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, China NMPA other global regulatory agencies).
- Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process.
- Bachelor's Degree in scientific discipline (e.g., Pharmacy, Biology, Microbiology, Chemistry, plus 5 years related experience; including but not limited to providing regulatory expertise in US PMA Class III products, EU MDR, and working on product lifecycle management systems.
- Master's Degree in scientific discipline (e.g., Pharmacy, Biology, Microbiology, Chemistry, plus 3 years related experience; including but not limited to providing regulatory expertise in US PMA Class III products, EU MDR, and working on product lifecycle management systems.
- Coursework, seminars, and/or other formal government and/or trade association training.
- Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
- Other incidental duties.
- Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Seniority level
Seniority level
Associate
Employment type
Employment type
Contract
Job function
Job function
Legal-
Industries
Pharmaceutical Manufacturing
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