"Lighting a Path to the Future"

Associate Director, CMC Regulatory Affairs (Device)

Location: Boston, MA
Job Type: Direct Hire
Salary: $139,000.00 - $180,000.00
Degree: Master;
Date: 11/1/2017
Job ID: 02537820
Job Description
Reporting to the Director of Regulatory Affairs, this key role is to function as global lead on device teams.
Ensure that submission content meets regulatory requirements. Strategize to identify risk areas and develop alternative courses of action. Manage scenario planning and development of regulators responses. Manage medical device Regulatory Affairs activities for developing global CMC medical device and IVD strategies across product life cycles & execution in North America. 

Support and development of risk management files, FMEAs, and Human Factors Studies.
Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions and interactions with the FDA, Notified Bodies, and Health Canada for device development issues supporting either stand-alone medical devices or combination products. Provide support to other Health Authority (HA) interactions as required.
Provide regulatory guidance and expertise to internal groups such as product life cycle development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned. 
Manage preparation of US regulatory filings in a timely manner to meet corporate objectives. Responsible for US, EU and OUS Regulatory Affairs for multiple medical device product lines filed as under 510(k), PMA, and EU Technical Files for medical devices, IVDs or combination products.
Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.


Serve as lead regulatory representative on cross-functional product teams, and applying advanced knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with government regulations. 

Develop global device regulatory strategy for one or more investigational and marketed products

Lead the preparation and filing of 510k, Technical Files and or CMC sections of regulatory submissions and interactions with regulatory agencies.

Review and approve technical documentation including technology transfer protocols, design validation, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.

Education & Experience Requirements:
• Advanced degree (PhD preferred) in engineering, biochemical engineering or related scientific discipline.
• Masters in Regulatory Affairs strongly preferred.
• Minimum of 10 years of related experience within a pharmaceutical/medical device company, CRO or similar organization and with minimum of 8 years International/Global regulatory experience in medical device and companion diagnostics development and registration activities.


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