Regulatory Affairs Specialist 2 CR (Temporary 12 months)

Location: Alajuela, Costa Rica

What you will do

• Respond to written questions from regulatory agencies and follow up on approvals for product changes.
• Maintain regulatory files for US and international submissions and documents.
• Interpret US and international regulatory guidelines and update regulatory procedures.
• Support product development teams in incorporating FDA and other regulatory authority requirements.
• Assist with international product registrations and regulatory information retrieval.
• Lead LATAM regulatory activities while coordinating with FDA, notified bodies, legal authorities, counsel, consultants, and international customers.

Requirements

• Bachelor’s degree in engineering, a related field, or equivalent.
• Minimum of 2 years of experience in a similar position.
• Knowledge of medical device regulations, including 21 CFR and FDA law.
• Ability to communicate regulatory requirements to technical functions and support regulatory relationships.
• Experience with document control systems such as Agile and Oracle.
• Intermediate Microsoft Office skills, plus internet and email proficiency.

Nice to have

• Knowledge of European medical device directives and international registration requirements.
• Medical device software submission and validation experience.
• Regulatory Affairs Certified Professional (RAC) certification.
• English and Spanish language skills.

Culture & Benefits

• Temporary 12-month position.
• Opportunity to support global regulatory operations with a focus on LATAM activity.
• Regular engagement with regulatory agencies, notified bodies, legal authorities, and external consultants.