Regulatory Affairs Specialist II in Alajuela, Alajuela at Theragenics Corp
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Job Description
Job Title: Regulatory Affairs Specialist II
Location: Coyol, Costa Rica
Modality: Hybrid with minimum 3 days in office
Travel: 0-25% domestic and international travel
Position Summary
Delivers comprehensive regulatory affairs assistance for both domestic and international markets concerning new and established medical devices. Engages in collaborative efforts to compile 510(k)s, Master Files, IDE, and PMA submissions, encompassing amendments and supplements. Participates in the preparation of Technical Files and Design Dossiers, fostering interaction with international affiliates and notified bodies to secure and uphold marketing approvals across global jurisdictions. Offers support in Quality Management System (QMS) operations, including surveillance, reporting, and label approvals as necessitated.
Key Responsibilities
- Regulatory Compliance:
- Partner with Quality, Engineering, Operations, & Document Control to:
- Ensure business is compliant with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDR, MDSAP, and applicable international regulations
- Coordinate the preparation, assembly, and submission of regulatory filings to obtain approvals for product development, clinical trials, marketing authorizations, and post-market including:
- 510(k)
- Technical Files
- Letters to File
- Product Registrations
- International market registrations
- Conduct internal audits and support customer audits as needed
- Provide regulatory guidance to project teams and facilitate communication between internal stakeholders and regulatory authorities.
- Stay abreast of evolving global regulatory requirements and guidelines relevant to the company's products and markets and proactively implement necessary changes.
- Interpret and communicate regulatory requirements to internal stakeholders to ensure compliance throughout the product lifecycle.
- Other responsibilities as assigned.
- Partner with Quality, Engineering, Operations, & Document Control to:
- Documentation Management:
- Partner with document control specialists to continuously improve documentation controls.
- Prepare, review, and submit regulatory documents such as applications, dossiers, and reports to regulatory agencies.
- Maintain organized and up-to-date regulatory files and databases.
- Other responsibilities as assigned.
- Regulatory Submissions:
- Coordinate the preparation, assembly, and submission of regulatory filings to obtain approvals for product development, clinical trials, marketing authorizations, and post-market activities.
- Contribute to the development of regulatory strategies and plans for new product development, including risk assessments, regulatory pathways, and timelines. Participate in regulatory agency meetings and negotiations as needed.
- Other responsibilities as assigned.
Required Qualifications
- A bachelor’s degree in a science or engineering field (like biology, chemistry, or pharmacy); advanced degree preferred
- 3 - 5 years working in a regulated field like clinical research or medical manufacturing
- Experience working with international manufacturing locations
- Experience with FDA, EU MDR, and MDSAP
- Fluent in both English and Spanish (written and verbal)
Preferred Qualifications
- Experience with Class II and/or Class III medical devices
- Experience supporting manufacturing operations in Latin America
- Regulatory Affairs Certification (RAC) and/or Regulatory Affairs Professionals Society (RAPS) membership preferred.