Compliance Assurance Specialist
2 weeks ago
Job Title: Compliance Assurance Specialist
Company: Augmentjobs
Salary Range: $80,000 to $120,000
Experience Level: 2-5 years
As a Compliance Assurance Specialist at Augmentjobs, you will play a vital role in guaranteeing that our offerings adhere to all applicable regulations and standards. Your collaboration with various teams will be essential in managing compliance submissions, ensuring adherence, and keeping abreast of regulatory changes.
Key Responsibilities:- Regulatory Adherence: Confirm that all products, processes, and documentation meet federal, state, and international regulations.
- Submission Management: Prepare and file compliance documents, including applications, reports, and correspondence with regulatory authorities.
- Documentation Oversight: Maintain precise records of compliance submissions, approvals, and communications. Ensure that documentation is current and easily accessible.
- Strategic Compliance Planning: Formulate and execute compliance strategies in partnership with cross-functional teams to facilitate product development and market entry.
- Regulatory Surveillance: Track changes in regulations and standards pertinent to the company's operations. Provide insights on the implications of these changes and implement necessary modifications.
- Collaborative Engagement: Collaborate with R&D, Quality Assurance, Marketing, and other departments to ensure compliance throughout the product lifecycle.
- Audit Readiness: Prepare for and engage in compliance audits and inspections. Address any issues or findings promptly and effectively.
- Training and Support: Offer training and guidance to internal teams regarding compliance requirements and best practices.
- Education: Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related discipline. An advanced degree is advantageous.
- Experience: 2-5 years of experience in compliance assurance or a related field, preferably within the industry.
- Knowledge: Comprehensive understanding of compliance requirements and processes, including FDA, EMA, and other relevant regulatory bodies.
- Skills:
- Exceptional written and verbal communication abilities.
- Strong attention to detail and organizational capabilities.
- Ability to analyze and interpret compliance guidelines and standards.
- Proficiency in compliance submission software and tools.
- Personal Attributes:
- Capacity to work independently and collaboratively.
- Strong problem-solving skills and the ability to manage multiple tasks simultaneously.
- Proactive and adaptable to a dynamic work environment.
- Competitive salary and performance-based bonuses
- Health, dental, and vision insurance
- 401(k) plan with company match
- Paid time off and holidays
- Professional development opportunities
To express interest in this position, please submit your resume and cover letter outlining your relevant experience and suitability for the role at Augmentjobs.
Augmentjobs is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.
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