Job description
About The Opportunity
Flywheel is seeking a Biomedical Software Compliance Coordinator to join our fast-paced and growing team. This is an exciting opportunity for a self-motivated person with a comprehensive knowledge and passion for regulatory compliance and the desire to readily engage in continuing education in an ever changing and evolving industry. The Biomedical Software Compliance Coordinator will report to and assist the Sr. Director of Regulatory Affairs with all compliance and regulatory maintenance across departments. The goal of this position is to assist with oversight and support of all aspects of Quality and Compliance program implementation and enforcement. The Biomedical Software Compliance Coordinator will be responsible for assisting in the development, review, processing, and staff training of quality documentation while maintaining the Quality Management System. The perfect candidate will also assist in all aspects of the internal and external audit and compliance process.
Environment
In this role, you will work closely with all departments as needed including Legal, QA, Engineering, IT, Product Development, Sales, HR, etc. reporting directly to the Sr. Director of Regulatory Affairs. We’re highly responsive to customer needs and constantly strive to make a positive contribution to the biomedical and life sciences communities we serve.
Team members are recognized and rewarded when advocating for customer success and satisfaction over other concerns. We value self-motivated, creative individuals who work well in a collaborative environment – constantly generating and sharing new ideas and solutions with the team.
Flywheel has a comprehensive benefits package and encourages a balanced work life and home life.
Responsibilities
- Assist in the management of compliance efforts.
- Assist with researching regulatory compliance requirements, evaluating adequacy of company policies, standards, procedures, and training material.
- Maintain knowledge of regulatory guidelines and ensure all company operations are adhering to these guidelines and that policies are updated and employees are retrained as modifications are made.
- Assist with the identification and assessment of the compliance program, risk and controls.
- Assist in the development, management, and implementation of compliance policies, procedures and guidelines to direct and carry out the objectives of Flywheel’s compliance program.
- Assist in the oversight of compliance adherence and effectiveness of Quality Assurance, Clinical Operations, and Product Development .
- Investigate, respond to, and possibly lead remediation activities around compliance incidents reported by personnel or clients.
- Provide compliance consultation as needed for vendors, clients and subcontractors to ensure proper documentation and policies are in place as they relate to Flywheel policies.
- Assist in performing internal annual company wide audits in conjunction with department leads and provide corrective action reports as needed.
- Assist with any external audits.
- Identifying regulatory non-compliance in a timely manner to allow Flywheel management to address and correct potential impacts before they become major risks to the company.
- Assist in overseeing an employee regulatory compliance training program following a responsibility matrix while maintaining accurate training records.
- Other responsibilities as required and assigned by the Sr. Director of Regulatory Affairs.
What would make you a great fit
- Bachelor’s Degree in Regulatory Affairs, Information Technology or related field or commensurate experience.
- Familiarity with regulations, guidelines and laws regarding biomedical imaging software, clinical trial data collection, validation, and processing.
- Experience assisting in audits of organizations in Biomedical or related industries.
- Experience developing and maintaining standard operating procedures and company compliance standards.
- Assisting corporate/industry compliance programs adhering to applicable industry standards and regulations HIPAA, GCP, GDPR - Regulations governing PII and PHI21 CFR Part 11, 21 CFR Part 820 - Healthcare regulations governing electronic records and signatures, quality and security in research and devices.
- Willingness to obtain training in: SOC 2, ISO 27001 and/or ISO 13485, ISO 27799, ISO 9001-Quality Management Systems.
- Administering Quality Management Systems for the storage and maintenance of company compliance documentation.
- Developing and implementing employee training programs for multiple compliance standards.
- 3 years experience assisting with compliance and regulatory functions for a company, preferably a biomedical informatics company supporting clinical trials both nationally and internationally.
- Knowledge and understanding of the company products and services.
- 3+ years experience in biomedical informatics, medical imaging, clinical trial operations, and medical research
Do you feel like you don't have everything that's listed above? If you have some of the skills and experience that we’re looking for and are willing to use your talent to learn the rest, we encourage you to apply!
About Us
Flywheel is the leading research data platform that's transforming the way biomedical and imaging data are managed at leading life sciences, clinical, and academic institutions globally.
Flywheel provides a comprehensive research data solution with all the tools needed for curation, imaging processing, machine learning workflows, and secure collaboration. By leveraging cloud scalability and automating research workflows, Flywheel helps organizations scale research data and analysis, improve scientific collaboration, and accelerate discoveries.
Company Values
GO STEADY WITH LEVITY
The alchemy of effective teamwork happens when we each take ownership of both the menial and the magical every day. We’re serious, but never stuffy. We keep our cool under pressure because we assume best intentions and maintain perspective. This allows for true teamwork, with a dash of irreverence.
WORK BETTER TOGETHER
We are tenacious and united in our pursuit of solving our customers’ biggest challenges, and no challenge is too big. Diverse backgrounds across our team make us more effective as we listen, absorb, collaborate, and iterate to innovate.
FIGURE IT OUT
We’re obsessed with uncovering the why of any given. Having an open mind allows us to be quick to fail and quick to adapt. We relentlessly pursue continual improvement through learning and imagining new possibilities.
GIVE A SHIT
We’re fueled by grit, boundless energy, and a deep belief that we are doing cool shit. We don’t hesitate to stand up and speak out because we trust that through tough, honest discourse we can drive change and make a real difference for our customers and our mission.
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