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Regulatory Affairs Specialist

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

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

Job Description

The Regulatory Affairs Specialist will support the product portfolio, manufacturing operations, and customer needs by contributing to all phases of the product lifecycle as required. This includes providing regulatory guidance, registering products, evaluating engineering changes with respect to regulatory compliance, maintaining required regulatory records and reports, and interacting with regulatory agencies and notified bodies. The individual will utilize semi-advanced knowledge of the regulatory environment and business principles while working under the direct supervision of the Quality/Regulatory Manager.

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 appropriate regulatory strategies.

+ Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to 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 determining 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 according to published regulations and/or customer expectations.

+ Strive for continuous improvements to the regulatory processes.

+ Communicate regularly and effectively with cross-functional personnel 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

+ Regulatory affairs expertise in medical devices and regulatory submissions.

+ Knowledge of regulatory documents and regulatory compliance.

+ Bachelor’s degree in a science, mathematics, engineering, or technology field preferred.

+ 5+ years of progressive experience in regulatory affairs required.

+ Experience with 21CFR 820, ISO13485, MDR QMS requirements preferred.

+ Experience with medical device products preferred.

Additional Skills & Qualifications

+ Experience with EPA regulations preferred.

+ Experience with EU MDR Technical Documentation preferred.

+ Experience with 510(k) submissions preferred.

+ Experience with Health Canada Licence submissions and amendments preferred.

+ RAPS or other regulatory certifications preferred.

+ Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook).

+ Problem-solving and analysis skills including statistical process control.

+ Technical capacity including decision making, communication, and reporting.

+ Strong interpersonal communication skills.

+ Organizational skills.

Work Environment

The employee can work fully remote. This is a full-time contract position requiring at least 40 hours per week, with hours of work and days scheduled determined by the Director of Regulatory/Quality. Special circumstances such as off-shift and weekend work might occur on rare occasions.

Pay and Benefits

The pay range for this position is $30.00 - $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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jun 17, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.