Senior Medical Device Regulatory Lead

Rhythmlink International LLC; Columbia (SC); On-site; USD 105,000 - 120,000; Full time

Job summary

Rhythmlink International LLC in Columbia, SC, seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for medical devices, supporting international and domestic compliance, design changes, and lifecycle management.

You will develop regulatory strategies, prepare technical documentation, and collaborate with engineering, quality, and operations to ensure timely, audit-ready deliverables and market authorizations.

Qualifications

• Advanced knowledge of medical device regulatory requirements including ISO 13485, FDA 21 CFR 820/QMSR, EU MDR 2017/745.
• Strong knowledge of design controls, engineering change control, document control, risk management, verification and validation, labeling controls, technical documentation, and product lifecycle management.
• Ability to independently support engineering product design projects and translate design, test, risk, clinical, labeling, and manufacturing information into regulatory conclusions and audit-ready documentation.
• Technical competency in biocompatibility, sterilization, packaging or shelf-life validation, process validation, test method validation, software validation, usability, electrical safety, EMC, or cybersecurity documentation.
• Ability to interpret complex regulations and apply them to regulatory strategy and compliance decisions.
• Strong technical writing skills with the ability to create regulatory assessments, submission content, and responses to regulator questions.
• Lead cross-functional discussions and manage multiple time-sensitive projects with attention to detail.

Responsibilities

• Regulatory lead for new product development, sustaining engineering, and lifecycle projects with cross-functional teams.
• Authors and maintains technical documentation compliant with EU MDR 2017/745 and other standards.
• Develop regulatory strategies for global product clearance and market access.
• Manage U.S. 510(k), EU technical documentation, and international registrations and responses.
• Evaluate design, manufacturing, labeling changes for regulatory impact.
• Support post-market regulatory activities and audits.

Skills

Regulatory knowledge

Design controls

Technical writing

Project management

Cross-functional leadership

Regulatory strategy

Education

Bachelor’s degree in engineering or life sciences

7+ years of regulatory affairs experience

EU MDR 2017/745 documentation experience

Regulatory submissions experience

RAC (Devices) preferred

Experience with medical devices regulatory submissions

Job description

Rhythmlink International LLC in Columbia, SC, seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for medical devices, supporting international and domestic compliance, design changes, and lifecycle management.

You will develop regulatory strategies, prepare technical documentation, and collaborate with engineering, quality, and operations to ensure timely, audit-ready deliverables and market authorizations.