Regulatory Specialist, Post Market Surveillance (Allendale, Nj)

Regulatory Specialist, Post Market Surveillance

Location: Allendale, NJ
Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment. As a Post Market Surveillance Analyst, you’ll be responsible for leading, maintaining, and continuously improving post market surveillance and risk management processes for the total product lifecycle. You’ll author PMSRs, PSURs, and CSRs, maintain risk management files, and assess risk profiles for the Spine portfolio.

What You’ll Do:

• Responsible for the leading and maintaining data integrity of post market surveillance processes
• Responsible for leading and maintaining creation and maintenance of post market surveillance documents according to regulation (EU) 2017/745 as well as MDD guideline 92/42 / EEC, ISO 13485 and FDA
• You support the creation of Post Market Surveillance plans and reports (PMS Report / PSURs) and are responsible for the creation and updating of all necessary PMS documents. This also includes the collection, evaluation and analysis of complaint data.
• Responsible for actively monitoring the market for our products and for coordinating PMS activities.
• Support the further development and optimization of the PMS system.
• You work across interfaces with various departments (medical affairs, development, risk management, clinical affairs).
• Implement and maintain internal procedures to comply with Post Market Surveillance regulations (Global)
• Maintain risk files and escalate risk related issues to cross functional teams
• Act as subject matter expert in internal and external audits

What You Bring:

• Bachelor’s degree in Engineering, Life Sciences, Statistics, Data Analytics, or relevant field; or equivalent work experience
• 0+ years of experience in post market surveillance and proficiency in a regulated environment
• Familiarity with BI tools and software coding (Power BI, Tableau, R/Python/SQL)
• Ability to translate regulatory requirements into dashboards, data visualizations, and trend analyses
• Understanding of statistical concepts and trending methodologies
• Adaptability to a fast-paced, dynamic environment
• Attention to detail with strong accuracy, efficiency, and consistency
• Ability to work independently and collaboratively
• Excellent interpersonal, written, and verbal communication skills
• Strong problem-solving and innovation mindset
• Effective time and project management skills
• Leadership potential
• Knowledge of spinal/orthopedic products preferred

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and shape strategy in the dynamic field of medical sales—positioning yourself to influence growth and innovation across the organization.

Compensation:
Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $75,000.00 - $105,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.

Benefits include:

• Comprehensive health, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company