Life Science RA Strategy Consultant

Location: 100% Remote, in Latin America

Status: Independent Contractor Role. (Affiliate Consultant)

#lifesciences, #consultant, #RAQA

This exciting role is for independent contractors with significant experience in the RA/QA aspects of the life science industry sub-sectors such as medical devices, in vitro diagnostics, lab-developed tests, pharmaceuticals, and cosmetics.

You will likely be an expert in regulatory affairs, helping designers, manufacturers and distributors of medical devices and IVDs navigate the filing requirements for multiple countries in Latin America and the US, including cross-border sample processing and reporting. 

We seek consultants, auditors, instructors, and those who have expertise and a passion for patient safety and population health improvement. We have good rates of compensation, defined by the project, and a top-rated team to work alongside you.

The roles are home-based and require the ability to travel to Buenos Aires to the client site on occasion. We therefore seek highly organized individuals who are self-starters, good communicators and are open to flexible work arrangements, seeking variety in the work they do.

You would be responsible for planning and delivering Life Science consulting engagements related to regulatory affairs strategy and infrastructure, appropriate to the level of risk in a target product.

Person Description

• A confident personality and competent in getting ideas across to others effectively
• Demonstrates the ability to work in a team environment, especially when operating remotely
• Has a passion for patient safety through effective regulatory and quality activities
• Respects the contribution of all colleagues and facilitates consensus on tough issues
• Demonstrates flexibility in day-to-day working in the team and approach to unique client issues
• An ability to fit in with client culture and get ideas across effectively
• Established as an independent contractor or contract-for-hire

Essential Base Qualifications

• Bachelor's degree in Engineering, Science, or Life Sciences related field
• A minimum of ten years experience in life science, preferably multi-country work
• Evidence of leading activities in their field (such as writing regulatory submissions)
• Significant experience in RA/QA matters related to any of:  medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics.

Essential Industry Requirements

• Experience with regulations across multiple countries in Latin America
• Experience with establishing a regulatory strategy that aligns with business goals and appropriate risks
• Experience with strategy, submissions, clinical evaluation, post-market surveillance, risk management
• Experience with ancillary standards such as ISO 17025:2017; ISO 14971:2019; ISO 27001:2013 ISO 13485:2016 a plus

Travel

Ability to travel across the region (10% - 15%). Occasional travel to the US may be required.

For a confidential discussion regarding this role, and our growing affiliate-based practice - please submit your CV/resumé and we will schedule a call.