Regulatory Affairs Specialist

The Metrix Company; Dubuque (IA); Sur place; USD 80 000 - 105 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) plan

Dental and vision insurance

Life insurance

Résumé du poste

The Metrix Company, a leading manufacturer of single-use medical devices, seeks a Regulatory Affairs Specialist to collaborate with Engineering and Quality Assurance to maintain regulatory knowledge and ensure compliance across US and international markets.

You will lead internal audits, manage submissions and regulatory files, review labeling and promotional materials, and guide audits by FDA and Notified Bodies while coordinating CAPA and post-market surveillance.

Qualifications

• Bachelor's degree in a healthcare/biomedical field and 3+ years in regulatory affairs or quality for medical devices.
• Experience maintaining ISO 13485, FDA 21 CFR 820, and related regulatory programs.
• Strong analytical, problem-solving, and cross-functional leadership skills.

Responsabilités

• Maintain regulatory knowledge base on regulations, standards, and guidance documents.
• Lead internal and supplier audits; develop schedules and track CAPA closures.
• Prepare submissions (510(k) and other filings) and maintain regulatory files.
• Coordinate with FDA audits, Notified Bodies, and customer audits; provide post-inspection information.
• Review labeling, IFUs, batch records and promotional materials for compliance.

Connaissances

Regulatory affairs

Quality assurance

Medical devices

FDA regulations

Auditing

CAPA

Formation

Bachelor of Science in Healthcare

Biomedical Science

Biology

Chemistry

Related field

Description du poste

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 3+ years of regulatory affairs, quality, ormedical 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.