What are the responsibilities and job description for the Regulatory Affairs Specialist position at ICONMA?
Top 3 Daily Responsibilities: (3 bullets of the main responsibilities on the assignment)
Working with cross-functional product and research teams to develop regulatory strategies to meet business objectives in a compliant manner
Prepare plans, reports and documented evidence for product development and research projects to demonstrate adherence to regulatory requirements
Support creation and review of external content (blogs, research papers, presentations) to assure that company statements and claims are compliant with global regulatory requirements
Skill/Experience/Education
Mandatory7 years of experience in medical device regulatory affairs in global markets Experience in US and international regulation of SaMD Experience in the preparation/clearance of FDA 510(k) submissions and international medical device submissions Bachelor's degree in health/physical sciences, engineering or related field
DesiredAdvanced degree or professional certification in medical device regulatory affairs
Knowledge of clinical research methodology and providing advice to teams conducting clinical evaluations and investigations in accordance with the ISO 14155 and GCP
Experience in medical device standards development and compliance (e.g. AAMI, IEC, ISO)
Experience with the EU MDR including in relation to device classification, the GSPR, UDI, Vigilance/PMS, and clinical investigations.
Experience with standalone SaMD mobile apps, wearable applications, or other consumer facing health solutions.
Experience negotiating with international market regulators such as TGA, PMDA and ANVISA.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Working with cross-functional product and research teams to develop regulatory strategies to meet business objectives in a compliant manner
Prepare plans, reports and documented evidence for product development and research projects to demonstrate adherence to regulatory requirements
Support creation and review of external content (blogs, research papers, presentations) to assure that company statements and claims are compliant with global regulatory requirements
Skill/Experience/Education
Mandatory7 years of experience in medical device regulatory affairs in global markets Experience in US and international regulation of SaMD Experience in the preparation/clearance of FDA 510(k) submissions and international medical device submissions Bachelor's degree in health/physical sciences, engineering or related field
DesiredAdvanced degree or professional certification in medical device regulatory affairs
Knowledge of clinical research methodology and providing advice to teams conducting clinical evaluations and investigations in accordance with the ISO 14155 and GCP
Experience in medical device standards development and compliance (e.g. AAMI, IEC, ISO)
Experience with the EU MDR including in relation to device classification, the GSPR, UDI, Vigilance/PMS, and clinical investigations.
Experience with standalone SaMD mobile apps, wearable applications, or other consumer facing health solutions.
Experience negotiating with international market regulators such as TGA, PMDA and ANVISA.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Salary : $112 - $145
