Boston Scientific Sr Regulatory Affairs Specialist - 

Peru, Lima, Lima 

303996011

Your Responsibilities will Include

• Develop local strategies for regulatory approval in collaboration with Marketing, Planning, and International Division teams.
• Coordinate, compile, and submit regulatory filings for new and modified products to DIGEMID.
• Coordinate, compile, and prepare regulatory documentation for Tenders purposes.
• Review product and manufacturing changes for compliance with applicable regulations and assess the impact on regulatory filings.
• Coordinate the localization process to ensure compliance with Peru´s labeling requirements.
• Review promotional materials.
• Represent Regulatory Affairs on cross-functional projects, providing regulatory feedback and guidance, including involvement in process changes, continuous improvement efforts, and acceleration towards digital transformation.
• Foster positive relationships with regulatory agencies and industry associations through verbal and written communications, acting as the focal point for regulatory advocacy in Peru.
• Ensure that the quality assurance system in the stages of reception, storage, and distribution guarantees the conservation, stability, and quality of pharmaceutical products, medical devices, and health products, and for controlled products, their custody.
• Control that the commercialization of products is carried out exclusively to pharmaceutical establishments, commercial establishments, or the final consumer, as appropriate.
• Order the withdrawal from the market of products or devices from batches, series, or identification codes, when necessary, and communicate the fact, when appropriate, to the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (ANM), the decentralized body of the national health authority (OD), or the corresponding Regional Health Authority (ARS) through the Regional Authority of Pharmaceutical Products, Medical Devices, and Health Products (ARM). Authorize the marketing of products or devices after verifying their compliance with the specifications approved in the sanitary registration.
• Verify that there are no contaminated, adulterated, falsified, altered, expired products or devices in poor condition or other sanitary observations. If this is the case, they will be withdrawn from sale and placed in the low area or rejected, duly identified and sealed for subsequent destruction. In the case of allegedly falsified products or devices, this situation must be communicated to the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (ANM) or the corresponding Regional Health Authority (ARS) through the Regional Authority of Pharmaceutical Products, Medical Devices, and Health Products (ARM).
• Verify that official books or electronic data records are kept up to date and remain in the establishment.
• Train and supervise assistant and technical staff in the correct performance of their duties.
• Ensure the accuracy of the statements, documentation, and information submitted to request the Sanitary Registration or its modification.
• Notify suspected adverse reactions and adverse incidents of pharmaceutical products, medical devices, or health products, in the authorized format in physical or electronic form validated and within the deadlines established in local regulations if stricter than BSC.
• Develop and maintain a database for recording adverse reactions and incidents.
• Maintain the confidentiality of notifications of suspected adverse reactions and adverse incidents.
• Report to the National Authority of Pharmaceutical Products, Medical Devices, and Health Products (ANM) the quality control analysis protocols or quality control test reports of the batches entering the market, as established by local regulations.
• Custody the technical documentation related to the products or devices marketed.
• Comply with and enforce Good Storage Practices and Good Distribution and Transportation Practices and, where appropriate, Good Pharmacovigilance Practices.
• Verify that the promotion and advertising produced and disseminated in drugstores comply with current regulations.
• Verify compliance with local health regulations.
• Approve, custody, and keep updated all technical documentation concerning the Sanitary Registration of the medical devices entrusted for reconditioning.
• Ensure the accuracy of the statements, documentation, and information submitted to request the Sanitary Registration or its modification.

Required Qualifications:

• Bachelor's Degree in Pharmacy, licensed to assume Technical Direction.
• Solid experience in the medical device Regulatory Affairs field.
• Knowledge of DIGEMID regulations.
• Advanced proficiency in English.
• Experience in interactions with regulators: Regulatory Intelligence, Advocacy, and/or Policy.
• Ability to read, analyze, and interpret general, scientific, and business periodicals, as well as governmental regulations.
• Excellent attention to detail with the ability to identify trends and gaps.
• Ability to manage databases in software and systems.
• Effective communication of complex ideas, both verbally and in writing, good drafting skills.
• Team player with excellent interpersonal skills and strong problem-solving skills.

Preferred Qualifications:

• General knowledge of global or LATAM regulations is an asset.