Planet Pharma
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https://www.propharmagroup.com
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HM's Top Needs:
Education Required: Bachelor’s degree
Years’ Experience Required: 3-4 years
Regulatory Operations specialist would lead the submission content management, submission publishing in US & EU, regulated master data management including UDI data collection & submission, new & changing regulations assessment, regulatory processes & QMS procedure updates. This person would be responsible for maintaining device listings, product licensing, facility registrations and providing audit support for FDA, NB & International agency audits. RA ops specialist role would be highly collaborating with cross-functional team in preparing submission content and keeping up overall regulatory compliance.
Responsibilities may include the following and other duties may be assigned. Responsible for the preparation publication quality control and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents eCTD. Submissions are produced with electronic publishing tools in compliance with document management standards. Responsible for activities related to enterprisewide regulatory management systems including systems coordination training others developing and implementing plans and providing input to systems designs. Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors. Prepares submits tracks indexes and archives paper and electronic submissions including information amendments annual reports general correspondence adverse event reporting and promotional materials.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
Sr Regulatory Operations Spec
5290 California Avenue Irvine, CA 92617 US
Posted: 10/02/2024
2024-10-02
2024-11-13
Employment Type:
Contract
Job Category: Regulatory Sciences and Medical Writing
Job Number: 614615
Is job remote?: No
Country: United States
Job Description
HM's Top Needs:
-
Regulatory Operations experience in medical device industry including submission publishing device listings CFGs UDI data collection amp reporting QMS updates.
-
Experience with RIM systems amp tools reporting tools such as Power BI Business Objects Regulated master data management
-
Understanding of Medical Device regulations in US amp EU including types of submissions change notifications new amp changing regulations assessments.
Education Required: Bachelor’s degree
Years’ Experience Required: 3-4 years
Regulatory Operations specialist would lead the submission content management, submission publishing in US & EU, regulated master data management including UDI data collection & submission, new & changing regulations assessment, regulatory processes & QMS procedure updates. This person would be responsible for maintaining device listings, product licensing, facility registrations and providing audit support for FDA, NB & International agency audits. RA ops specialist role would be highly collaborating with cross-functional team in preparing submission content and keeping up overall regulatory compliance.
Responsibilities may include the following and other duties may be assigned. Responsible for the preparation publication quality control and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents eCTD. Submissions are produced with electronic publishing tools in compliance with document management standards. Responsible for activities related to enterprisewide regulatory management systems including systems coordination training others developing and implementing plans and providing input to systems designs. Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors. Prepares submits tracks indexes and archives paper and electronic submissions including information amendments annual reports general correspondence adverse event reporting and promotional materials.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
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