Senior Technical Writer

Job Summary

1) Design, develop, and optimize primary, secondary, and tertiary packaging systems for medical devices. 2) Develop packaging specifications, drawings, BOMs, and technical documentation. Execute package validation activities in accordance with: a) ISO 11607 Parts 1 & 2 b) ASTM standards c) ISTA transportation testing protocols d) PPWR 3) Perform package integrity, seal strength, aging, and distribution testing. 4) Support sterile barrier system development and validation. 5) Participate in design control activities, risk management, CAPA, audits, and change control processes for packaging component 6) Prepare and maintain packaging validation reports and technical files. 7) Evaluate packaging designs for compliance with European Union PPWR requirements. 8) Support implementation of packaging minimization strategies while maintaining medical device 9) performance and sterility requirements. 10) Assess packaging material selection for recyclability, reuse, and sustainability objectives. 11) Collaborate with sustainability and regulatory teams to ensure packaging documentation aligns with PPWR requirements. 12) Monitor changes in EU packaging legislation and provide impact assessments for existing and future products. 13) Support packaging labeling and material declaration requirements associated with PPWR compliance.

Key Responsibilities

1) EU PPWR

Skill Requirements

PPWR Regulations

Client communication

Other Requirements