About MasterControl:
MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit www.mastercontrol.com.
SUMMARY
As a Compliance Specialist at MasterControl, you will be responsible for ensuring that our products, processes, and systems comply with industry standards and regulatory requirements. You will work closely with cross-functional teams to implement and maintain compliance programs, conduct audits, and provide guidance on compliance matters. Your expertise will be critical in minimizing risks and ensuring that MasterControl adheres to all relevant regulations and standards.
RESPONSIBILITIES
- Develop, implement, and maintain compliance programs to ensure adherence to industry standards and regulatory requirements (e.g., FDA, ISO, GDPR, HIPAA).
- Conduct internal audits and assessments to evaluate compliance with regulatory requirements and company policies.
- Identify compliance risks and work with relevant departments to develop and implement corrective actions.
- Provide guidance and training to employees on compliance matters, policies, and procedures.
- Collaborate with cross-functional teams to ensure that compliance requirements are integrated into product development, manufacturing, and operational processes.
- Monitor changes in regulatory requirements and industry standards, and update compliance programs and policies accordingly.
- Prepare and maintain documentation related to compliance activities, including audit reports, risk assessments, and corrective action plans.
- Support external audits and inspections by regulatory agencies and customers, ensuring that all necessary documentation and evidence are available.
- Assist in the development and review of standard operating procedures (SOPs) to ensure compliance with regulatory requirements.
- Analyze compliance data and metrics to identify trends and areas for improvement, and report findings to senior management.
- Stay current with industry best practices and emerging trends in compliance engineering and regulatory affairs.
PREFERRED SKILLS
- Proven experience in compliance engineering or a related role, with a strong understanding of regulatory requirements and industry standards (e.g., FDA, ISO, GDPR, HIPAA).
- Strong analytical and problem-solving skills, with the ability to assess compliance risks and develop effective mitigation strategies.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and provide clear guidance on compliance matters.
- Detail-oriented and highly organized, with the ability to manage multiple tasks and priorities.
- Proficiency in using compliance management software and tools.
- Relevant industry certifications (e.g., Certified Compliance Engineer, Certified Regulatory Compliance Manager) are highly desirable.
- Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.
EDUCATION AND TRAINING
- Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.
- Proven experience in compliance engineering or a related role.
- Relevant industry certifications (e.g., Certified Compliance Engineer, Certified Regulatory Compliance Manager) are highly desirable.
PHYSICAL DEMANDS AND WORKING CONDITIONS
- Must be able to work well under pressure and manage multiple priorities.
- Ability to operate a computer and work at a desk for extended periods of time.
- Ability to communicate effectively in writing, in person, over the telephone, and in an e-mail.
- Office environment with regular use of computer and extended periods of sitting and standing.
- Ability to travel occasionally for audits, inspections, and training.
Why Work Here?
#WhyWorkAnywhereElse?
MasterControl is a place where Exceptional Teams come together to do their best work. In fact, hiring Exceptional Teams is a core value of ours. MasterControl employees are surrounded by intelligent, motivated, and collaborative individuals. We like to call it #TheBestTeamOnThePlanet.
We work hard to develop and challenge our employees' skillsets, recognize their contributions, encourage professional development, and offer a one-of-a-kind culture. This is why we say #WhyWorkAnywhereElse?
MasterControl could be your next (and last) career move!
Here are some of the benefits MasterControl employees enjoy:
- Competitive compensation
- 100% medical premium coverage (yes, you read that right!)
- 401(k) plan with company match
- Generous PTO packages that increase with tenure
- Schedule flexibility
- Fitness clubs (you get paid to have fun and be active!)
- Company parties and employee recognition programs
- Wellness programs (free Fitbit, gym membership and athletic shoe reimbursements, etc.)
- Onsite physician and massage therapist
- Innovation center and gaming rooms at the office
- Dental/vision plans
- Employer paid life insurance policy
- Much, much more!
Applicants must be currently authorized to work in the United States on a full-time basis.
The US base salary range for this full-time position is $70,000 - $90,000 + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
MasterControl is an Equal Opportunity Employer. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact [email protected] or call (801) 942-4000 and ask to speak with a member of Human Resources.
Equal Opportunity Employer, including disability and protected veteran status
Top Skills
What We Do
In short, we help bring life-changing innovations to more people, sooner. How we do it is a longer story.
It starts with our cloud-based Product Lifecycle Excellence platform. More than 1000 of the world’s most innovative and highly regulated companies use it to improve quality and stay in compliance at every step of their product journey – from concept to commercialization.
We have more than 500 employees who come to work every single day with a singular focus: to help our customers improve quality. We do it in many ways. And we can do it for you.
We’ll help you build quality into your product design processes. You’ll get a streamlined system to track clinical trials, organize the data, and submit results for approval by regulatory agencies around the world.
You can digitize, automate and accelerate quality processes to build a culture of quality throughout your organization. Increase visibility and ensure compliance throughout your supply chain. And help your manufacturing teams eliminate the tradeoffs between line performance and product quality.
Once your product is out in the market we give you the ability to manage in-market complaints and close the quality loop.
In other words, we help you make quality a priority throughout your company. And that’s important. Because when you’re trying to impact people’s lives, quality changes everything.
