"Alerted.org

Regulatory Affairs Specialist

The Metrix Company

1 Positions

ID: 85128

Posted On 12/12/2025

Job Overview

The Metrix Company, a leading manufacturer of single-use medical devices, is seeking a quality-driven Regulatory Affairs Specialist to join our team. This person will work directly with Engineering and Quality Assurance to maintain the knowledge base of existing and emerging regulations, standards, or guidance documents. The Regulatory Specialist is responsible for maintaining regulatory compliance as new or revisions of standards and product designs are released. This person will also be the technical expert in resolving potential regulatory issues, deficiencies, and questions from regulatory agencies. Other duties include:

+ Assures regulatory compliance to ISO 13485, FDA 21 CFR 820, and Medical Device Single Audit Program. Lead the audit program to ensure ongoing compliance. Develop and maintain the annual internal audit schedule, plan and conduct risk-based internal audits, oversee auditor training/qualification, and track timely closure of audit findings.

+ Assists in maintaining the Company’s Quality Management System (QMS) and assists in the review and development of standard operating procedures (SOP’s) which support regulatory compliance to standards, customer requirements, and objectives.

+ Supports and provides regulatory expertise for sustaining efforts and design development projects for the domestic and international markets for medical devices. Prepares and submits, registrations, licensing, submission files, 510(k), and other product submissions according to regulatory requirements. Maintains regulatory files and databases for product compliance.

+ Communicates with regulatory agencies, provides oversight to ensure that the company is compliant with US, Canada, and international regulatory requirements.

+ Makes recommendation based on corrective / preventive action (CAPA’s) investigations of regulatory / quality issues.

+ Analyzes complaints and works with Contract Clinical Reviewer to make recommendations regarding their reportability (US, Canada and as needed). Coordinates recall or market withdrawal activities, as necessary. Maintains post market surveillance and reporting requirements.

+ Guides inspectors during FDA inspections, Notified Body audits, customer audits, and other such audits; provides post-inspection information as requested.

+ Reviews product promotional materials, IFU’s, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and standards.

+ Generates, identifies, and maintains regulatory documentation, completes gap assessments, and maintains databases, or systems to sustain regulatory compliance.

+ Prepares responses to customer or third-party requests for information, such as product data, written regulatory statements, surveys, or questionnaires.

+ Reads, reviews, interprets, and keeps current with regulations and publications with primary focus on medical devices.

+ Assists with maintaining Safety Data Sheet (SDS) system injunction with California Prop 65 regulatory and SEC Conflict Materials requirements.

Qualified candidates will possess a Bachelor of Science degree in Healthcare, Biomedical Science, Biology, Chemistry, or related field with 1-3 years of regulatory affairs, quality, or medical device experience. Lead Auditor experience preferred. Strong analytical and problem-solving capabilities are necessary with a proven ability to lead teams, manage complex regulatory projects, and influence cross-functional decision-making. Exceptional communication skills and computer proficiency required, including Microsoft Office and database programs.

The Metrix Company offers an excellent compensation and benefits package, including health, dental, optical, life, disability insurance, and 401k plan with a generous employer match.

Candidates must be authorized to work in the United States. Employer will not sponsor applicants for work visas.

Primary Contact

12799

Karen Smith

Human Resources,

563-556-8800

Phone

Phone

Phone

Fax

[email protected]

Email

True

False

True

Job Details

Categories

Architecture/Engineering/Drafting

Environmental/Quality Assurance/Safety

Industrial

Technical

Location

Dubuque, IA

Shift

First Shift

Job Type

Employee

Full/Part

Full Time

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Retirement Plan

PTO (Paid Time Off)

Paid Holidays

Qualifications

Education

Bachelors

Experience

1-2 Years

Company ID

1277

Job REQ #

\# Positions

1

Start Date

20251212

End Date

20260228

Featured Job

TH Ad

0

TH Comments

Similar Jobs

Managed Network Services Specialist

Managed Solutions Group

Quality Control Specialist

Sedona Staffing Services

Share this Job

The Metrix Company

About the Company

The Metrix Company, incorporated in 1964, is an ISO 13485 and FDA-registered medical device manufacturer. Metrix is globally positioned to meet specialty and high-volume product demands with ISO Class 8 cleanroom manufacturing in Dubuque, Iowa and San Cristobal, Dominican Republic.

Metrix serves a variety of markets, including medical device, biopharmaceutical and veterinary industries. The product line consists primarily of single use devices, collection bags, waste bags, TPN and enteral nutrition bags. Our design, quality and production teams have decades of experience in radio frequency welding, heat sealing, assembly and packaging to ensure the highest quality products.

We appreciate your interest in employment opportunities at The Metrix Company. As a family-owned business, Metrix employs a dedicated staff who provide support for both of our manufacturing facilities. If you are energetic and quality driven, with a proven record of success, we want to hear from you!