Regulatory Affairs Specialist (Engineer - Remote)

Enovis Corporation

Job Overview

Location

Tijuana, Baja California, Mexico

Job Type

Full-time

Full Job Description

📋 Description

• As a Regulatory Affairs Specialist (Engineer - Remote) at Enovis Corporation, you will play a critical role in ensuring patient safety and regulatory compliance by managing the end-to-end complaint handling and adverse event reporting process for medical devices distributed globally, directly supporting the company’s mission to deliver clinically differentiated solutions that improve patient outcomes.
• You will monitor vigilance activities, assess complaints for reportability under FDA MDR, EU Vigilance, and international regulations, prepare and submit mandatory reports (initial, supplemental, final) to the FDA, European NCAs, and other global authorities, lead recall efforts for US and international products, conduct Health Hazard Evaluations, liaise with Corporate QARA, Legal, and clinical teams, track investigations through CAPA closure, and generate regulatory summaries such as ASR, PSR, and PSUR — all while ensuring adherence to ISO 13485, FDA 21 CFR Parts 803, 806, 820, and MEDDEV 2.12.
• Enovis Corporation is a NYSE-listed, innovation-driven medical technology leader committed to transforming orthopedic care and active lifestyles through integrated technologies, continuous improvement, and a global talent culture; this role sits within a collaborative, mission-focused QARA team that values precision, accountability, and cross-functional partnership to uphold the highest standards of product safety and regulatory excellence.
• In this role, you will deepen your expertise in global medical device regulatory frameworks, sharpen your analytical and decision-making skills under pressure, gain hands-on experience with international reporting systems (FDA, EMA, MHRA, etc.), and develop leadership in crisis response scenarios — positioning you for advancement into senior regulatory, quality assurance, or product safety management roles within the fast-growing medtech sector.

🎯 Requirements

• Bachelor of Science degree in biology, health sciences, engineering, or another discipline
• 3+ years of experience in the medical device industry, specifically in complaint handling, adverse event reporting, or regulatory affairs
• Proficient in English with strong written, oral, and presentation communication skills
• Knowledge of Microsoft Office applications and ability to quickly learn other required software
• Detail-oriented with proven ability to maintain high accuracy in data entry, document preparation, and analysis under tight regulatory timelines
• Strong decision-making and prioritization skills, with demonstrated initiative to act independently in high-volume, dynamic environments

🏖️ Benefits

• Remote work flexibility from Tijuana, Baja California, Mexico
• Opportunity to work with a NYSE-listed, innovation-driven medical technology company impacting global patient outcomes
• Exposure to complex international regulatory environments (FDA, EU, IMDRF, etc.) and real-world recall and vigilance management
• Professional growth in a culture of continuous improvement with access to cross-functional collaboration across QA, Legal, Clinical, and Product teams
• Contribution to meaningful work that directly supports patient safety and product compliance in the orthopedic and medtech space

Skills & Technologies

Onsite

Degree Required

Ready to Apply?

Apply Externally

You will be redirected to an external site to apply.

Enovis Corporation

Visit Website

About Enovis Corporation

Enovis Corporation develops, manufactures, and distributes medical technology products for orthopedic surgery, rehabilitation, and pain management. Its portfolio includes joint replacement implants, surgical instruments, bracing and support devices, and digital health solutions designed to improve patient mobility and surgical outcomes. Operating globally, the company serves hospitals, orthopedic surgeons, and physical therapists with evidence-based products and services across the continuum of musculoskeletal care.

View Company Profile

Get more remote jobs like this

Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.

Weekly remote jobs and featured talent.

No spam. Only curated remote roles and product updates. You can unsubscribe anytime.