To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $40 to $50 an hour. 

Industry: Pharmaceutical
Work Type: Contract
Contract Duration: Through end of 2026 (Extension based on performance and business needs)

Job Summary:
This role is responsible for leading biocompatibility and nonclinical safety evaluations for medical devices, biomaterials, and combination products within a regulated environment. The position serves as a subject matter expert in ISO 10993 based biological risk assessments and ensures compliance with global regulatory standards. The role supports both new product development and on market product changes while collaborating with cross functional teams including manufacturing, regulatory, and research and development. The incumbent will contribute to defining scientific strategies, executing evaluation plans, and ensuring product safety throughout the lifecycle. This position plays a critical role in supporting regulatory submissions and maintaining compliance with evolving global requirements.

Key Responsibilities:

• Lead biocompatibility assessment strategies and ensure compliance with ISO 10993 and global regulatory requirements
• Develop and author biological risk assessments technical reports and scientific documentation supporting regulatory submissions
• Plan and support safety evaluation studies for medical devices and combination products
• Collaborate with cross functional teams including manufacturing regulatory quality and research and development
• Support change control activities for on market products and assess biological impact of product changes
• Conduct gap assessments based on updated regulatory guidelines and standards
• Engage and manage external research partners and contract research organizations for outsourced studies
• Prepare and present scientific findings and technical reports to internal and external stakeholders

Required Qualifications:

• Bachelor degree in Life Sciences Biomedical Engineering or related field with minimum 6 years experience OR Master degree with minimum 4 years experience
• Strong knowledge of ISO 10993 FDA guidance EU MDR and animal welfare regulations
• Experience in biocompatibility and nonclinical safety evaluations in medical device or pharmaceutical industry
• Experience managing outsourced studies including GLP non GLP and GMP environments
• Strong technical writing and communication skills
• Experience with change control quality systems and on market product support

Preferred Qualifications:

• Experience with combination products or biologics
• Experience supporting regulatory submissions for global markets
• Strong analytical and problem solving skills
• Experience working with contract research organizations and external laboratories
• Knowledge of product development lifecycle in medical device industry

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)