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Regulatory Affairs Specialist

2 months ago

Austin, United States augmentjobs Full time
Job DescriptionJob Description

Job Description:

We are seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for our products or services. This role involves preparing regulatory submissions, coordinating with regulatory agencies, and maintaining compliance documentation.

Roles and Responsibilities:

  1. Regulatory Submissions:

    • Prepare and submit regulatory filings, applications, and reports to regulatory agencies (e.g., FDA, EMA, Health Canada) for product approvals, registrations, and compliance.
    • Ensure submissions are accurate, complete, and submitted within specified timelines.

  2. Regulatory Compliance:

    • Monitor regulatory changes, guidelines, and requirements related to our industry and products.
    • Interpret regulations and implement compliance strategies to ensure adherence to regulatory standards.

  3. Documentation and Record Keeping:

    • Maintain regulatory documentation, including product dossiers, technical files, and regulatory correspondence.
    • Ensure documentation is organized, up-to-date, and accessible for audits and inspections.

  4. Quality Assurance Support:

    • Collaborate with quality assurance teams to implement regulatory requirements into quality management systems (QMS).
    • Participate in internal audits and assessments to verify compliance with regulatory standards.

  5. Communication and Liaison:

    • Serve as the primary contact for regulatory agencies and authorities regarding regulatory submissions and inquiries.
    • Communicate regulatory requirements and updates to cross-functional teams and stakeholders.

  6. Risk Assessment and Management:

    • Conduct risk assessments and impact analyses related to regulatory changes and non-compliance issues.
    • Develop and implement risk mitigation strategies to address potential regulatory risks.

  7. Regulatory Strategy Development:

    • Assist in developing regulatory strategies for product development, market entry, and lifecycle management.
    • Provide regulatory guidance and support to product development teams and stakeholders.

  8. Training and Education:

    • Provide training on regulatory requirements and compliance procedures to internal teams.
    • Stay informed about industry trends, best practices, and regulatory developments through continuous learning and professional development.

Skills and Qualifications:

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Biology, or related field; advanced degree or relevant certifications (e.g., RAC) preferred.
  • X+ years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, or related industry.
  • Strong knowledge of regulatory requirements and guidelines (e.g., FDA regulations, ISO standards).
  • Experience with regulatory submissions (e.g., 510(k), PMA, CE Mark) and interactions with regulatory agencies.
  • Excellent organizational skills with attention to detail and accuracy in documentation.
  • Effective communication skills, both written and verbal, with the ability to influence and negotiate.
  • Ability to work independently and collaboratively in a team environment.
  • Proficiency in MS Office suite and regulatory information management systems/software.

Compensation:

  • The salary for this position is competitive and commensurate with experience.
  • Benefits package includes health insurance, retirement plan options, paid time off, and professional development opportunities.

Application Process:

Please submit your resume, cover letter, and any relevant certifications or portfolio demonstrating your experience in regulatory affairs. We will contact selected candidates for further interviews.

This job description is designed to attract qualified candidates for a Regulatory Affairs Specialist position by outlining specific responsibilities, required skills, and offering details about compensation and benefits. Adjustments can be made based on the company's industry, size, and specific regulatory affairs needs, such as specialization in particular markets (e.g., pharmaceuticals, medical devices) or regulatory environments (e.g., global regulatory compliance).