On-site for the first three weeks then REMOTE
Mon - Friday (8am - 4:30 pm)
Job Description:
The position is responsible for managing device complaints and adverse events globally. This may include: complaint initial triage, submitting regulatory reports in accordance with applicable
regulations, referring potential safety cases to applicable department, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.
Key Responsibilities:
•Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.
•Responsible for creating and submitting regulatory reports to the FDA.
•Works independently and is accountable for completing task as assigned.
•Works well in a team to accomplish team goals.
Top Skills:
Regulatory affairs, Medical device, Regulatory submission, FDA, Regulatory compliance, Strategy
Skills & Qualifications:

• Bachelors Degree in Engineering, Medical Sciences or other related scientific field
• 2 years of experince in healthcare environment, and/or within a quality/compliance/regulatory organization
• Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.
• Basic computer and software skills.
• Must be able to communicate effectively with internal and external customers.
• Demonstrate ability to collect, analyze and interpret complaint and adverse event information.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.