Regulatory Affairs Specialist
3 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Vision Achievement. As a key member of our Life Sciences team, you will be responsible for planning and delivering consulting engagements related to quality and regulatory affairs infrastructure.
Key Responsibilities- Plan and deliver Life Science consulting engagements related to quality and regulatory affairs infrastructure
- Develop and implement quality systems, including design control and process validation
- Conduct audits and assessments to ensure compliance with regulatory requirements
- Provide expert advice on regulatory matters, including submissions remediation and clinical evaluation
- Collaborate with cross-functional teams to ensure effective implementation of quality and regulatory initiatives
- Bachelor's degree in Engineering Science or a Life Sciences-related field
- Significant experience in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics
- Experience with auditing, design and manufacturing, interpretation and application of codes, regulations, and standards (GMP)
- Experience with quality systems planning and implementation, design control, and process validation
- Experience with 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
- Ability to travel extensively domestically (25-50%) and occasionally internationally
Vision Achievement is a leading provider of Life Sciences consulting services. We are committed to helping our clients achieve their goals through expert advice and guidance. Our team of experienced professionals is dedicated to delivering high-quality services that meet the needs of our clients.
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