Quality Assurance and Regulatory Affairs Manager
Build the quality system. Own the submissions. Figure out the regulations.
About the Role
OrthoSelect makes software and hardware devices designed to transform the practice of orthodontics. As the company continues to expand its business, we are looking for a skilled and experienced individual to lead the company’s quality assurance and regulatory compliance initiatives.
This role owns design, implementation, and management of the company’s quality system, as well as ensuring compliance with government rules and regulations. The role is currently an individual-contributor position, though the position could grow over time, which means the work is both strategic and hands-on. The incumbent writes the procedures, runs the design reviews, conducts the internal audits, sits across the table from auditors, and works on the production floor with operators to ensure proper implementation and compliance. This is an opportunity for the right person to both build and implement a first-class program.
Who We Are Looking For
This role demands the ability to run a complex, multi-year program, to manage multiple interwoven priorities, and to lead multiple internal and external stakeholders to ensure projects stay on track to timely completion.
To this end, we are looking first and foremost for a strong project manager: someone who can take a large, ambiguous body of requirements, break it into a step-by-step plan, hold people to it, and produce written documentation that is easily implementable and compliant with demanding government regulations. If you come from technical program management, technical writing, documentation, systems or process engineering, or a compliance-driven field, we want to talk to you.
While we would ideally like someone who has experience in medical device quality and compliance, we would also be interested in someone who brings strong skills in other areas and the ability to quickly learn the specifics of FDA regulation.
What This Role Owns1. The Quality System
- Keep the quality system working in practice, not just documented on paper
- Write and approve quality manuals, procedures, and work instructions
- Administer eQMS, including user access, workflows, and validation of the system itself
- Control documents and records, including retention periods
- Run management review and drive the resulting actions to closure
- Set quality objectives and report performance to leadership
2. Regulatory Approvals and Market Access
- Decide and defend how each product is classified in each market
- Prepare and defend FDA 510(k) submissions, including software and cybersecurity sections
- Keep registrations current
- Serve as the company’s point of contact for government and auditing bodies
- Manage outside regulatory consultants, and independently verify what they deliver
- Build and own multi-year plan for expanding regulatory approval and compliance in new markets
- Track regulatory changes and flag what they mean for our existing approvals
3. After the Product Ships
- Investigate complaints and production issues
- Decide what must be reported to government agencies and file those reports
- Own CAPA, including root cause analysis and effectiveness checks
- Own recalls, corrections, and advisory notices
- Watch trends in post-market data and feed what they show back into design and risk
4. Audits, Training, and Advising the Business
- Plan and run internal audits across the entire quality system
- Host inspections and audits, and own the responses and corrective action plans
- Audit suppliers as needed
- Define competence requirements and train team members whose work affects product quality
- Review marketing materials for compliance
- Advise leadership on the regulatory impact of new products, features, markets, and business arrangements
QualificationsRequired
- Project management track record — you have owned a complex, cross-functional program with real deadlines and stakeholders
- Strong technical writing ability — you can turn complex requirements into procedures and documentation that can be easily understood and followed
- Bachelor’s degree in science, business, or a related field — or equivalent relevant experience
- 3+ years in a role requiring documented process, technical rigor, and attention to detail (engineering, manufacturing, software, healthcare, or another regulated or highly technical environment)
- Able to read primary source text — regulations, standards, specifications — and interpret correctly
- Able to work independently and make decisions when the requirements are ambiguous
- Comfortable working on the production floor with operators and supervisors
- Self-directed learner — you have taught yourself an unfamiliar technical domain before
- Genuine interest in becoming the company’s expert on medical device regulation and implementing programs to ensure strong compliance
Strongly Preferred
- Experience in a regulated environment of any kind — medical device, pharma, aerospace, automotive, food, or a formal audit framework such as ISO 9001, SOC 2, or HIPAA
- Exposure to quality management systems, document control, or CAPA processes
- Familiarity with design controls, Design History Files, or a comparable engineering change-control discipline
Nice to Have
- Working knowledge of ISO 13485 and FDA quality system requirements (21 CFR Part 820)
- Participation in an FDA 510(k) submission
- Experience hosting a regulatory audit or inspection
- Risk management under ISO 14971
- MDSAP, Health Canada, or TGA experience
- Software as a Medical Device experience, including IEC 62304
- EU MDR technical documentation experience
- Greenlight Guru or another eQMS platform
- RAC, CQA, or CQE certification
What You Get
- Paid Time Off. Accrues from Day 1, usable after 90 days. Doubles after your third year.
- 9 paid company holidays per year. Full-time gets 8 hrs paid per holiday.
- Your birthday off, paid. Completely separate from your regular PTO — it’s a gift on top.
Financial Benefits
- 401(k) with company match. 100% on the first 1% you contribute, then 50% on the next 5% — up to 3.5% of your pay in free retirement contributions. New in 2026.
- HRA — tax-free medical reimbursements. Pay a doctor’s visit, prescription, or ER bill out of pocket, then submit it back to us to be reimbursed pre-tax.
- Tuition reimbursement up to $1,000/semester. Any class, any program, any field — finish a C or better and we cut you a check at the end of the semester.
- Employee referral bonus. $200 per successful hire. No cap.
- Working Advantage discount portal. Hotels, theme parks, rental cars, concerts, movies — typical savings of 10–40% off retail.
Why This Role Is Worth Taking
You will be the company’s authority on quality and regulatory initiatives. You will interact directly with company leadership and you will develop a specialized, durable skill set in medical device regulatory affairs. If you are a strong program manager looking to advance your career, this is that step.
Pay: $30.00 - $40.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
Work Location: In person
