Regulatory Affairs Specialist
hace 1 semana
Company Overview: Vision Achievement, a leading provider of life sciences consulting services, is seeking an experienced Regulatory Affairs Specialist to join our team. This exciting opportunity allows you to leverage your expertise in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.
Job Description: As a Regulatory Affairs Specialist, you will be responsible for planning and delivering high-quality consulting engagements related to quality/regulatory affairs infrastructure. Your primary focus will be on working with clients to identify and mitigate risks associated with their products, ensuring compliance with relevant regulations and standards. You will work closely with our team of experts to provide guidance on design and manufacturing, interpretation and application of codes, regulations, and standards, GMP, quality systems planning and implementation, and submissions remediation.
Key Responsibilities:
- Lead the instruction of Life Sciences experts in RA/QA matters.
- Develop and implement effective regulatory strategies to ensure client compliance with relevant regulations and standards.
- Conduct risk assessments and develop mitigation plans to address identified risks.
- Collaborate with cross-functional teams to deliver high-quality consulting engagements.
Required Skills and Qualifications:
- Bachelor's degree in Engineering, Science, or Life Sciences related field.
- Significant experience in RA/QA matters related to one or more of medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.
- Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.
- Strong analytical and problem-solving skills, with the ability to think critically and strategically.
- Ability to travel extensively domestically (25% - 50%), with occasional international travel required.
Salary: $80,000 - $120,000 per year, based on experience and qualifications. This salary range reflects the company's commitment to compensating its consultants fairly and competitively, while also taking into account the specific requirements and demands of this role.
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