Regulatory Affairs Specialist - Contract

INTERESTED CANDIDATES MAY SEND UPDATED RESUMES TO: JGASSER @ ACTALENTSERVICES.COM

OR TEXT JENNA TO SETUP PHONE INTERVIEW: 419. 980. 5823

Responsibilities:

Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.Assist in maintaining the Quality Management System to ensure domestic and international standards are met.Define and document corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies.Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and Technical Files.Provide technical assistance to other departments in the determination of testing requirements to comply with medical device and electrical safety regulations.Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.Review, analyze and approve validations as appropriate.Provide assistance interdepartmentally in the formal assessment of risk in accordance to published regulations and/or customer expectations.Strive for continuous improvements to the regulatory processes.Communicate regularly and effectively with cross-functional personnel in order to achieve desired objectives.Complete special projects as assigned by the Quality / Regulatory Manager.Adhere to and promote all organizational policies and procedures.

Essential Skills

Bachelor’s degree in a science, mathematics, engineering, or other technology field is preferred.1-3 years of experience in regulatory affairs required.Prior knowledge of 21CFR 820, ISO13485, MDR QMS requirements preferred.Experience with medical device products preferred.Experience with EPA regulations preferred.Experience with EU MDR Technical Documentation preferred.Experience with 510(k) submissions preferred.Experience with Health Canada License submissions and amendments preferred.Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, PowerPoint, Outlook).

Additional Skills & Qualifications

RAPS or other regulatory certifications preferred.Problem-solving/analysis including statistical process control.Technical capacity including decision making, communication, and reporting.Strong interpersonal communication skill set.Organizational skills.

Pay and Benefits

The pay range for this position is $20.00 - $30.00/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 fully onsite position in Cuyahoga Falls,OH.

Application Deadline

This position is anticipated to close on Feb 27, 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.