Boston Scientific Regulatory Affairs Specialist II Costa Rica 

Costa Rica 

217559921

Position Responsibilities:

• Coordinate, compile, and submit regulatory filings for new and modified products to Costa Rica and Central America Health Authorities.
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings;
• Monitor and assess regulatory updates for compliance with applicable regulations and impact to regulatory filings, communicate relevant changes to internal stakeholders.
• Collaborate cross-functionally with global and regional RA counterparts, legal representatives, commercial, marketing, and operations teams to ensure aligned execution of regulatory priorities and approvals.
• Maintain current and accurate information in regulatory systems regarding status, approvals, and product licenses.
• Develops and maintains positive relationships with regulatory agencies and industry associations through verbal and written communications.
• Coordinates localization process to guarantee Costa Rica and Central America labeling requirements are met.
• Provide regulatory input on promotional, labeling, and advertising materials in line with Central America regulations.
• Serve as the RA point of contact for consultants and distributors to ensure accurate and compliant submissions.

Required Qualifications:

• 3-5 years of experience as a Regulatory Affairs Specialist in medical devices in Costa Rica and Central America countries.
• Knowledge of Central American regulations.
• Bachelor’s degree in Life Sciences (Pharmacy, Biochemistry, Biomedical Engineering or associated areas);
• Advanced English;
• Attention to detail and ability to identify trends, gaps etc.
• Problem-solving skills;
• Ability to communicate complex ideas clearly and simply both verbally and in writing;
• Ability to effectively manage multiple projects and priorities;
• Team player with excellent interpersonal skills.

Preferred Qualifications:

• General knowledge of global or LATAM regulations is an asset.
• Experience with interactions with regulators: Regulatory Intelligence and Advocacy.