To Apply for this Job Click Here
IDR is seeking a Regulatory Affairs Specialist to join one of our top clients in a remote capacity. This role is pivotal in ensuring product safety and compliance with regulatory standards for medical devices. If you are looking for an opportunity to join a growing organization and work within an ever-growing team-oriented culture, please apply today!
Position Overview/Responsibilities for the Regulatory Affairs Specialist:
• Identify, assess, and communicate product safety risks, developing action plans to address them effectively.
• Ensure compliance with global medical device reporting and complaint management standards, collaborating with European Headquarters and other stakeholders.
• Provide expert guidance to regulatory agencies and participate in investigations of potentially reportable events, analyzing data and documentation.
• Track and report on all stages of the investigation process, including data analysis, documentation review, and complaint coordination.
• Assist with investigations, including failure analysis and corrective actions, working closely with Engineering, Manufacturing, and Quality Assurance teams.
Required Skills for Regulatory Affairs Specialist:
• 3-5 years of experience in a highly regulated environment, preferably in the medical device or pharmaceutical industries.
• Experience in Quality, Product Safety, Product Surveillance, or Vigilance is preferred.
• Strong customer and service orientation with a conscientious, reliable, and independent work style.
• Excellent communication and conflict resolution skills, with a high sense of personal accountability.
• A 4-year degree or equivalent experience is required, with commercial or medical training preferred.
What's in it for you?
Competitive compensation package
Full Benefits; Medical, Vision, Dental, and more!
Opportunity to get in with an industry-leading organization
Close-knit and team-oriented culture
Why IDR?
25+ Years of Proven Industry Experience in 4 major markets
Employee Stock Ownership Program
Medical, Dental, Vision, and Life Insurance
ClearlyRated's Best of Staffing® Client and Talent Award winner 12 years in a row
#LI-Remote
IDR is an equal opportunity employer. We provide reasonable accommodations for disabled employees and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, criminal history, or any other protected category under applicable federal, state, or local laws. We consider all qualified applicants, including those with criminal histories, in compliance with applicable Fair Chance laws. To comply with civil rights laws, we invite applicants to voluntarily self-identify their race, ethnicity, gender, and veteran status. This information is confidential, optional, and will not affect your application. You may access this form here. Pursuant to pay transparency laws, salary ranges and benefits will be disclosed where required by law. Compensation is based on factors such as experience, skills, and qualifications. If you require a reasonable accommodation during the application or interview process, please contact Human Resources at hr@idr-inc.com