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Align Technology
Align Technology

45 Align Technology Regulatory Affairs Associate Jobs Hiring Near You

Align Technology

Sales Associate - January Class

Tempe, AZ · On-site

$13.50 - $18.50/hr

US-Arizona-Tempe-Corp HQ Description Role summary This position is ideal for someone looking to enter the medical device sales profession as a Sales Associate at Align Technology. The sales associate ...

Align Technology

Director, International Tax

San Jose, CA · Hybrid

$217K - $299K/yr

In this role, you will lead Align Technology's international tax function including compliance ... Monitor legislative and regulatory changes and assess impact on business operations and tax ...

Align Technology

Director, International Tax

San Jose, CA · On-site

$217K - $299K/yr

In this role, you will lead Align Technology's international tax function including compliance ... Monitor legislative and regulatory changes and assess impact on business operations and tax ...

Align Technology, Inc.

Sr. R&D Engineer

Morrisville, NC · On-site

$97K - $134K/yr

... Regulatory, and Operations to identify unmet needs, evaluate new technologies, develop and test ... Partner with Clinical Affairs and cross-functional teams to support clinical studies and other ...

Align Technology, Inc.

Lead the marketing strategy and execution for France and Benelux, ensuring full alignment with EMEA ... technologies. * Strong analytical and project management skills; ability to interpret data and ...

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Align Technology Jobs Information

Does Align Technology pay people when they’re sick?

Yes. Most people get paid when they’re sick.
100% of people say they would get paid if they were sick but scheduled to work.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

At Align Technology, are sick days and vacation days separate paid time off?

Sick days and vacation days are separate paid time off.
80% of people say they don’t have to use vacation days when they’re out sick.
Based on data from 5 people who took the Breakroom Quiz between May 2025 and January 2026.

Do people get paid time off at Align Technology?

Most people get paid time off work.
100% of people say they get paid time off.
Based on data from 5 people who took the Breakroom Quiz between May 2025 and January 2026.

How easy is it to get time off at Align Technology?

Most people find it easy to get time off.
100% of people report it’s easy to get time off.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

How easy is it to take sick days at Align Technology?

Most people find it easy to take sick days.
100% of people report that it’s easy to take time off if they are sick.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

Do people at Align Technology feel treated with respect by their managers?

Most people feel treated with respect by their managers.
100% of people say they’re treated with respect by their managers.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

Do people at Align Technology get to take their breaks without interruption?

Most people get breaks without interruption.
80% of people report that they get to take their breaks without interruption.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

Is it stressful to work at Align Technology?

Some people feel stressed out here.
40% of people say they often feel stressed out at work.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

Do people at Align Technology enjoy their jobs?

Most people enjoy their job.
100% of people report they enjoy their job.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

Do people at Align Technology recommend working with their team?

Most people recommend working with their team.
67% of people report that they would recommend working with their immediate team to a friend.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and January 2026.

Do people get enough training when they start at Align Technology?

Most people got enough training when they started.
80% of people report they got enough training when they started working here.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

Do workers feel well informed about how Align Technology is doing?

Only some people feel well informed about how the company is doing.
40% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and January 2026.

What other companies are hiring for Regulatory Affairs Associate jobs?

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Infographic showing various Regulatory Affairs Associate job openings at Align Technology in the United States as of August 2026, with employment types broken down into 97% Full Time, and 3% Contract. Highlights an 63% Physical, 3% Hybrid, and 34% Remote job distribution.

Sr. Quality Systems & Compliance Engineer

Align Technology

San Jose, CA • On-site

$137K - $188K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 5 days ago

Align Technology rating

8.4

Company rating: 8.4 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Description
We are seeking a Sr. Quality Systems professional to support and continuously improve the effectiveness of the Quality Management System (QMS) within a regulated medical device environment.

This role requires broad QMS experience, strong independent judgment, and the ability to lead cross-functional initiatives with minimal direction. The successful candidate will work across multiple quality system processes to support compliance, improve effectiveness, drive continuous improvement, and strengthen overall QMS performance. The successful candidate will be intellectually curious, bring a continuous improvement mindset, proactively seek better ways of working, and embrace new technologies and tools to improve quality system effectiveness.

The ideal candidate understands how quality system elements interact, can identify risks and opportunities, and is capable of driving practical solutions across a diverse business. This role is primarily focused on site-level QMS effectiveness while participating in multi-site and global quality system initiatives as needed.

Role expectations
  • Lead and support key Quality Management System (QMS) processes.
  • Drive continuous improvement initiatives that enhance QMS effectiveness and compliance.
  • Support activities across CAPA, Nonconformance Management, Internal Audits, Management Review, Document Control, and Training.
  • Analyze quality system performance data and identify opportunities for improvement.
  • Author and maintain procedures, work instructions, forms, and quality system documentation.
  • Provide quality systems guidance, coaching, and support to cross-functional stakeholders.
  • Partner with Engineering, Manufacturing, Operations, Regulatory Affairs, and Quality teams to improve process effectiveness and business performance.
  • Support site audits, inspection readiness activities, and resolution of quality system issues.
  • Participate in multi-site and global quality system initiatives, harmonization efforts, and process improvement projects.

What we're looking for
Education: Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.

Experience: 
  • Typically 6–10 years of experience in Quality Systems, Quality Engineering, Compliance, or related quality disciplines within the medical device industry. 
  • Broad experience across multiple QMS processes and quality disciplines.
  • Experience conducting internal audits and supporting external audits or regulatory inspections. 
  • Demonstrated ability to lead cross-functional initiatives and drive actions to completion.
  • Experience working within multi-site quality systems preferred.
Skills:
  • Strong understanding of Quality Management System principles and practices.
  • Knowledge of medical device quality system requirements and industry standards.
  • Strong problem-solving, root cause analysis, and risk-based decision-making skills.
  • Ability to understand how quality system processes interact and impact overall business performance.
  • Ability to work independently, navigate ambiguity, and lead initiatives with minimal direction.
  • Leverages data, digital technologies, and emerging tools, including AI-enabled solutions, to drive efficiency and effectiveness.
  • Strong communication, collaboration, and influencing skills. Ability to communicate and influence across all levels of the organization.
  • Excellent organizational and project management capabilities.
  • Ability to mentor and guide teams in quality system compliance and continuous improvement practices.
Complementary Skills:
  • ISO 13485 Lead Auditor certification, ASQ Certified Quality Auditor (CQA), or equivalent auditor qualification. 
  • Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. 
  • Experience with electronic Quality Management Systems (eQMS) such as Arena or equivalent. 
  • Knowledge of risk management methodologies such as ISO 14971, PFMEA, or FTA. 
  • Lean, Six Sigma, or other continuous improvement training/certification.

Pay Transparency
If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically. 
 
For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S. 
 
Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.
General Description of All Benefits
We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.  
 
Family Benefits.  Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings),  dental, and vision in accordance with those plans.  Align also offers to employees:
  • Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
  • Back-up Child/Elder Care and access to a caregiving concierge
  • Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans
  • Breast Milk Delivery and Lactation Support Services
  • Employee Assistance Program
  • Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan
Employee benefits.  Align offers its employees:
  • Short-term and long-term disability insurance in accordance with those plans.
  • Basic Life Insurance and Accidental Death and Dismemberment.  Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
  • Flexible Spending Accounts – Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
  • 401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%.). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
  • Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
  • Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days.  Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
  • Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
  • 11 Company-designated paid holidays throughout the year.
  • If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave.  All parental leave must be completed within one year of the birth or placement of the child.  Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
  • Non-exempt employees will receive full pay for up to 10 days of jury duty.  Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.  
To the extent applicable state or local law offers more generous benefits, Align complies with any such law. 

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