Adverse Event Specialist

Job Title: Adverse Event Specialist

Job Description

The Adverse Event Specialist manages product complaint remediation and evaluates new complaints to determine medical device report (MDR) requirements in accordance with FDA regulations and internal procedures. This role reviews both historical and newly received complaints, ensures that MDR submissions fully comply with 21 CFR 803 and Quality System regulations, and supports global reporting obligations where applicable. The specialist works cross-functionally with quality, regulatory, R&D, operations, and other internal partners to ensure accurate, complete, and timely regulatory reporting.

Responsibilities

• Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.
• Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.
• Ensure all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and applicable Quality System regulations.
• Process new complaints for reportability and support product complaint remediation activities in accordance with established procedures.
• Work cross-functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.
• Prepare and submit MDRs through the FDA’s electronic submission portal (eMDR) for newly identified reportable events.
• Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations for adverse events.
• Apply medical device reporting and adverse event expertise to support ongoing post-market surveillance and safety monitoring activities.
• Maintain accurate documentation of complaint evaluations, MDR decisions, and submissions in accordance with GxP and GCP principles.
• Contribute to continuous improvement of complaint handling and MDR evaluation processes by providing feedback on decision trees, criteria, and procedures.

Essential Skills

• Bachelor’s degree in a relevant field.
• At least 1 year of experience in complaint handling, MDR evaluation, post‑market surveillance, regulatory affairs, or other relevant experience within a regulated environment or healthcare.
• Minimum of 2 years of hands-on experience with medical device reporting under 21 CFR 803.
• Working knowledge of FDA regulations related to Medical Device Reporting (MDR) and 21 CFR 803.
• Experience with adverse event assessment and medical device reporting processes.
• Familiarity with pharmacovigilance, drug safety, case processing, and surveillance concepts.
• Experience in regulatory affairs within a pharmaceutical, medical device, or similarly regulated setting.
• Understanding of GxP and Good Clinical Practice (GCP) principles.
• Ability to interpret and apply regulatory criteria, definitions, and decision logic consistently.
• Strong attention to detail and accuracy in documentation and regulatory submissions.
• Effective cross-functional communication and collaboration skills.

Additional Skills & Qualifications

• Experience working with FDA electronic submission portals such as eMDR.
• Background in pharmaceutical, medical device, or related life sciences industries.
• Exposure to post-market surveillance programs and safety monitoring activities.
• Ability to work with international regulatory contacts to support global reporting obligations.
• Strong analytical and problem-solving skills for evaluating complex complaint files.
• Organizational skills to manage multiple complaints and MDR evaluations simultaneously.

Work Environment

This role operates in a hybrid work environment, with on-site attendance required on Tuesdays, Wednesdays, and Thursdays in Mundelein, IL, and remote work on other days as applicable. The position supports a large medical-surgical products and supply chain organization that serves diverse points of care, offering exposure to a highly regulated and quality-focused setting. Work involves regular use of regulatory systems and electronic portals, including the FDA’s eMDR submission platform, and collaboration with cross-functional teams such as Quality, Regulatory Affairs, R&D, and Operations. The environment emphasizes compliance with FDA regulations, 21 CFR 803, Quality System requirements, and GxP/GCP standards, with a professional office setting and structured processes for complaint handling and medical device reporting.

This is a Contract to Hire position based out of Mundelein, IL.

The pay range for this position is $35.00 - $40.00/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)

This is a hybrid position in Mundelein,IL.

This position is anticipated to close on May 12, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $35 - $40