Regulatory Affairs Specialist
Job DescriptionJob Description New RA position dedicated to the Reusable Pen Platform and its 2 strategic customers with Client for Pen and Pen needles registered in over 80 countries.
This is an excellent contract to hire opportunity to gain hands of experience in regulatory field with Business-to-Business customer exposure, global submission activity, regulatory intelligence reviews, health authority interactions/audits, and project management.
General Function:
Drive Global implementation and customer deliverables for Reusable Pen platform per PS RA team Strategy Main
Responsibilities:
Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation Effective Collaboration with multiple stakeholders i.
e.
internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance Identify ways to improve the efficiency of current work process and best practices as necessary.
Education:
B.
S.
degree in a technical discipline (e.
g.
, pharmacy, engineering, biology, chemistry).
Advanced degree preferred.
Experience:
Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management) Medical device and international registration experience is a must.
Combination Products knowledge or experience is a plus.
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint.
Recommended Skills Attention To Detail Auditing Biology Customer Experience Engineering Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
This is an excellent contract to hire opportunity to gain hands of experience in regulatory field with Business-to-Business customer exposure, global submission activity, regulatory intelligence reviews, health authority interactions/audits, and project management.
General Function:
Drive Global implementation and customer deliverables for Reusable Pen platform per PS RA team Strategy Main
Responsibilities:
Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation Effective Collaboration with multiple stakeholders i.
e.
internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance Identify ways to improve the efficiency of current work process and best practices as necessary.
Education:
B.
S.
degree in a technical discipline (e.
g.
, pharmacy, engineering, biology, chemistry).
Advanced degree preferred.
Experience:
Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management) Medical device and international registration experience is a must.
Combination Products knowledge or experience is a plus.
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint.
Recommended Skills Attention To Detail Auditing Biology Customer Experience Engineering Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
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