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$285k - $330k
...investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...Suggested$192k - $239k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...SuggestedInterim roleSummit Therapeutics Sub, Inc.
Palo Alto, CA14 days ago$118.5k - $139k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...SuggestedContract workWork at officeSummit Therapeutics Sub, Inc.
Menlo Park, CA2 days ago$200k - $250k
...competence and excellent communication skills, both oral and written. Successfully led Phase III regulatory submissions to FDA, EMA, NMPA, PMDA, etc. Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and...Suggested$197.3k - $394.7k
...with ISO 10993 and applicable global regulatory guidance. Provide expert input for regulatory submissions (IDE, PMA, 510(k), CE, NMPA, etc.) and represent the function during audits and agency interactions. Maintain strong awareness of evolving global biocompatibility...SuggestedFull time- ...with scientists, engineers, and clinicians, both internally and externally, as well as regulatory agencies including the FDA, PMDA, NMPA, and EMA Lead biostatistics continuous improvement initiatives Required Qualifications Master's degree with 5+ years or PhD...SuggestedFull timeRemote workWork from homeVisa sponsorship
$190k - $230k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...Suggested$184k - $230k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...Suggested- ...manage time efficiently. Advanced proficiency with Microsoft Office Suite. DESIRED: National Property Management Association (NMPA) certification Previous experience using Johnson Space Center (JSC) Electronic Document System (EDS). Previous experience...SuggestedContract workFor contractorsWork at officeLocal areaWeekend workAfternoon shift
$115k - $197.8k
...is maintained in compliance with ISO 13485 and ISO 14971 processes. Stay current with global regulatory changes (EU MDR, FDA, China NMPA, etc.) impacting EMC and safety compliance and communicate updates to internal stakeholders. Support regulatory submissions and audits...SuggestedTemporary workLocal areaFlexible hours$184k - $230k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...SuggestedWork at officeLocal area$184k - $230k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...SuggestedContract work$245k - $307k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...SuggestedContract workFor contractors$174k - $204.5k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...SuggestedContract workWork at office- ...not limited to, 21 CFR Part 820, ISO 13485, MDSAP country related requirements TGA, ANVISA RDC 665, CMDR, MHLW MO 169, IVDD, IVDR, NMPA, TAIWAN-MEDDEV-QMS. Travel, Motor Vehicle Record & Physical/Environment Requirements: ~ Ability to travel domestically and internationally...SuggestedWork experience placementLocal areaImmediate startNight shift
$186k - $233k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...$79.7k
...environment. Knowledge of GLP regulations is desirable. Experience with regulatory body submissions, including FDA, EU MDR, PMDA, or NMPA. Proficiency with Microsoft Word, Excel, PowerPoint, Minitab, and other data analysis tools. Requisition ID: 618524...Hourly payWork at officeLocal areaWorldwideRelocationRelocation packageShift work3 days per week$128k - $192k
...development principles, industry best practices, and regulatory expectations (including those of US FDA, EMA/NBs, UK MHRA, and China NMPA). Effective communication with stakeholders and a commitment to sharing knowledge for mutual growth are essential. You will join...$201.17k - $321.88k
...provide recommendations. Coordinates and leads audit activities with all global regulatory agencies (e.g. FDA, Notified Bodies, PMDA, NMPA etc.) Creates and maintains Compliance department internal methodology and procedures that comply with applicable domestic and...Full timeLocal areaWorldwide$122k - $143k
...investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...Full time$137.1k
...technical and business process solutions to complex problems ~ Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC) ~ Complete understanding of medical device project management principles, theories &...Hourly payWork at officeRemote workShift workBD
Lakewood, CO6 days ago$140k - $160k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...$231k - $285k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...$137.1k
...technical and business process solutions to complex problems ~ Knowledge of global medical device regulatory requirements (FDA, Anvisa, NMPA, MDR) and quality standards (ISO, GB, JISC) ~ Complete understanding of medical device project management principles, theories &...Hourly payWork at officeRemote workShift workBD
Lakewood, CO6 days ago$225k - $280k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of...$255.8k - $401.94k
...record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO). Actively engaged in major industry associations (e.g. EFPIA, PhRMA, AAPS, PDA, ISPE, DIA) and joint regulator/industry...Minimum wageFull timeTemporary workLocal areaRemote work$150k - $230k
...lab operations and preparing for health authority inspections. ~ Strong understanding of global regulatory requirements (FDA, EMA, NMPA, ICH M10, E6). ~ Exceptional leadership and people management skills with a record of developing scientific talent and fostering...Full time$158k - $185k
...investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...Remote work$231k - $289k
...investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview...Full time- ...global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, NMPA (CHN). Perform research to drive development of regulatory strategy for the assigned clinical development program. Lead and drive...
