Regulatory Affairs and Quality Assurance Instructor
2 weeks ago
Location: 100% Remote, within the USA
Residency Requirements:
Must be a US Citizen or permanent resident.
Employment Status:
Independent Contractor Role.
Client:
Vision Achievement
About the Role:
This position is designed for independent contractor instructors with extensive expertise in the Regulatory Affairs (RA) and Quality Assurance (QA) sectors of the life sciences industry, including medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.
You will be expected to possess a deep understanding of the design, manufacturing, and oversight of RA/QA in accordance with relevant regulations and standards.
We are looking for consultants, auditors, and instructors who are passionate about patient safety and enhancing population health.
Compensation:
Competitive rates defined by project, with a supportive and esteemed team to collaborate with.
Work Environment:
The roles are home-based, requiring the ability to travel to client locations for presentations or to deliver services via virtual platforms.
We seek highly organized, self-motivated individuals who are effective communicators and are adaptable to flexible work arrangements, enjoying a variety of tasks.
Key Responsibilities:
- Plan and execute consulting engagements related to quality and regulatory affairs, tailored to the risk level of the target product.
- Primarily function as an individual contributor while also engaging in teamwork.
Candidate Profile:
- Confident communicator with the ability to convey ideas effectively.
- Demonstrated capability to work collaboratively in a remote environment.
- Strong commitment to patient or consumer safety through regulatory and quality practices.
- Respectful of colleagues' contributions and skilled in facilitating consensus on challenging issues.
- Flexible in daily operations and approaches to unique client challenges.
- Established as an independent contractor or contract-for-hire.
Essential Qualifications:
- Bachelor’s degree in Engineering, Science, or a related Life Sciences field.
- Proven track record of increasing responsibility and leadership in relevant activities (e.g., regulatory submissions).
- Significant experience in RA/QA concerning medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.
- Experience in instructing life sciences professionals on RA/QA topics.
Industry Requirements:
- Familiarity with design and manufacturing processes, as well as the interpretation and application of regulations and standards, including GMP.
- Experience in quality systems planning, implementation, design control, and process validation.
- Knowledge of submissions, remediation, clinical evaluation, post-market surveillance, and risk management.
- Familiarity with ancillary standards such as ISO 17025:2017, ISO 14971:2019, and ISO 27001:2013 is advantageous.
Travel Requirements:
- Willingness to travel domestically (25% - 50%), with occasional international travel as needed.
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