Regulatory Affairs Specialist III
- Employer
- CorTech LLC
- Location
- Milwaukee
- Salary
- 31.42 - 52.85 USD Hourly
View more
- Industry
- Government and Public Services
- Role
- Other
- Job Type
- Other
- Hours
- Full Time
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Job Description
Front Line Care (FLC) is a business unit of client focusing on medical devices that enable earlier diagnosis and treatment. The sooner the diagnosis-the more options for effective treatments. Our smart screening devices and diagnostic tools empower clinicians and health systems to identify and treat every patient with confidence, shortening the path to assessment and then to care. The FLC portfolio includes products for vision screening & diagnostics which focus on preventing blindness by facilitating early detection and treatment; physical exam &diagnostic tools; diagnostic cardiology connected electrocardiograph products; and respiratory care devices.
The MDR Regulatory Affairs (RA) Specialist is responsible to build and deliver on regulatory strategies and technical documentation to support regulatory submissions in US, Canada and EU for Front Line Care medical devices. This individual will collaborate closely with other regulatory experts in these markets or other regulatory experts in other markets to achieve the best possible outcomes for effective product registration. This individual is responsible for a broad range of products in the Front Line Care portfolio. The MDR RA Specialist supports new and sustaining product development teams and will work closely with cross functional team members to assist with regulatory issues related to such items as labeling, marketing claims and testing requirements. The RA Specialist is an individual contributor and reports directly to the US Manager of Regulatory Affairs.
Essential Duties &Responsibilities
???Plan, coordinate and prepare regulatory documents in support of MDR
???Construct and manage EU MDR technical files
???Review product labeling including advertising and promotional materials for compliance
???Manage registration plans through collaboration with global RA peers
???Review and approve test compliance reports and associated technical documentation
???Review scientific/engineering materials including protocols and test reports
???Provide global performance and safety requirements as an input to product design teams
???Provide regulatory assessment on proposed changes to marketed devices
???Support international product registration regulatory colleagues
Education, Experience and Qualifications:
???Bachelor's degree is required. Engineering, biology, or science related field preferred.
???Minimum 2 years' experience in regulatory affairs. Advanced degree may be considered as partial fulfillment of experience.
???Proven ability to contribute creative yet practical solutions to problems
???Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies
???Strong project planning, leadership, negotiation, and presentation skills
Travel: Less than 5%
Front Line Care (FLC) is a business unit of client focusing on medical devices that enable earlier diagnosis and treatment. The sooner the diagnosis-the more options for effective treatments. Our smart screening devices and diagnostic tools empower clinicians and health systems to identify and treat every patient with confidence, shortening the path to assessment and then to care. The FLC portfolio includes products for vision screening & diagnostics which focus on preventing blindness by facilitating early detection and treatment; physical exam &diagnostic tools; diagnostic cardiology connected electrocardiograph products; and respiratory care devices.
The MDR Regulatory Affairs (RA) Specialist is responsible to build and deliver on regulatory strategies and technical documentation to support regulatory submissions in US, Canada and EU for Front Line Care medical devices. This individual will collaborate closely with other regulatory experts in these markets or other regulatory experts in other markets to achieve the best possible outcomes for effective product registration. This individual is responsible for a broad range of products in the Front Line Care portfolio. The MDR RA Specialist supports new and sustaining product development teams and will work closely with cross functional team members to assist with regulatory issues related to such items as labeling, marketing claims and testing requirements. The RA Specialist is an individual contributor and reports directly to the US Manager of Regulatory Affairs.
Essential Duties &Responsibilities
???Plan, coordinate and prepare regulatory documents in support of MDR
???Construct and manage EU MDR technical files
???Review product labeling including advertising and promotional materials for compliance
???Manage registration plans through collaboration with global RA peers
???Review and approve test compliance reports and associated technical documentation
???Review scientific/engineering materials including protocols and test reports
???Provide global performance and safety requirements as an input to product design teams
???Provide regulatory assessment on proposed changes to marketed devices
???Support international product registration regulatory colleagues
Education, Experience and Qualifications:
???Bachelor's degree is required. Engineering, biology, or science related field preferred.
???Minimum 2 years' experience in regulatory affairs. Advanced degree may be considered as partial fulfillment of experience.
???Proven ability to contribute creative yet practical solutions to problems
???Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies
???Strong project planning, leadership, negotiation, and presentation skills
Travel: Less than 5%
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