Job Title: FDA/Medical Complaint Reporting Specialist

REQUIREMENTS:

• Bachelors Degree in Life Sciences
• 1 years of pharmaceutical or medical device industry experience in QA, Regulatory, R&D or related field
• FDA Knowledge - GMP GCP GLP GDP
• Microsoft Excel & Database Systems

The Medical Device Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders. 

The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. 

Job Description

The Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. The person will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

Responsibilities

• Decision maker for all reportability decisions
• Lead for all vigilance reporting, including local and global submissions
• Partner with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalate requests as appropriate
• Ensure that relevant stakeholders have visibility to the reporting and where they are in the process
• Manage regular reporting needs and external requests (e.g., from the FDA)
• Manage the timeline for end-to-end reporting
• Own translation services for reporting

Essential Skills

• Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products
• Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, and 211)
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures
• Solid written and verbal communication skills
• Organizational skills
• Knowledge and application of computer systems for word processing and complaint management
• Ability to work with cross-functional teams and interact effectively with peers and management

Pay and Benefits

The pay range for this position is $22.00 - $27.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in North Chicago,IL.

Application Deadline

This position is anticipated to close on Feb 12, 2025.

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.

Salary : $22 - $27