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Regulatory Affairs Auditor
2 months ago
Location: Fully Remote, within the USA
Residency Requirement:
Must be a US Citizen or permanent resident.
Employment Type:
Independent Contractor Role.
Client:
Vision Achievement
Industry: Life Sciences Consulting
This role is tailored for independent contractors with extensive expertise in the Regulatory Affairs and Quality Assurance sectors of the life sciences industry, including medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.
As a Regulatory Affairs Auditor, you will be expected to possess a deep understanding of auditing processes related to the design, manufacturing, and monitoring of regulatory compliance under applicable regulations. Candidates with experience across multiple jurisdictions, including the US, UK, and EU, are particularly sought after.
We are looking for professionals who are not only auditors but also consultants and educators, with a strong commitment to patient safety and enhancing population health outcomes. Competitive compensation rates will be offered, determined by the scope of each project, and you will have the opportunity to collaborate with a highly regarded team.
This position is home-based, requiring the ability to travel to client locations or deliver services through virtual platforms. We seek individuals who are highly organized, self-motivated, effective communicators, and adaptable to flexible work arrangements, while enjoying a diverse range of tasks.
Key Responsibilities:
- Plan and execute consulting engagements in the life sciences sector, focusing on quality and regulatory affairs tailored to the risk level of target products.
- Operate primarily as an individual contributor while fostering teamwork.
Candidate Profile:
- Confident communicator capable of articulating ideas effectively.
- Proven ability to collaborate in a remote team environment.
- Strong dedication to patient or consumer safety through regulatory and quality initiatives.
- Respectful of colleagues' contributions and skilled in achieving consensus on challenging topics.
- Flexible in daily operations and approach to unique client challenges.
- Established as an independent contractor or available for contract work.
Essential Qualifications:
- Bachelor’s degree in Engineering, Science, or a related Life Sciences field.
- Demonstrated progression in responsibilities and leadership within the field, including regulatory submissions.
- Significant experience in Regulatory Affairs and Quality Assurance for medical devices, in vitro diagnostics, pharmaceuticals, or cosmetics.
Industry Requirements:
- Experience in auditing design and manufacturing processes, along with interpreting and applying relevant codes, regulations, and standards.
- Familiarity with quality systems planning, implementation, design control, and process validation.
- Knowledge of submissions, remediation, clinical evaluation, post-market surveillance, and risk management.
- Experience 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%) and occasional international travel may be necessary.
