Regulatory Affairs Manager

Job Description

Required: (Remote Opportunity - Temp to Perm)

• The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.

• In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.

• The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.

• Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.

Key responsibilities:

• Lead Regulatory Associates or Specialists in addition to work as an individual contributor

• Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)

• Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. 

• Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.

• Monitor and provide management with impact of changes in the Regulatory environment.

• Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.

• Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.

• Support Design Control process.

• Prepare Rational to file documentation for modifications to devices when appropriate.

• Participate in FDA & other notified body Inspections.

• Author and/or review regulatory procedures and update as necessary.

• Review change control documents and ascertain Regulatory impact for external and internal documents.

• Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.

• Review promotional material and labeling for regulatory compliance.

Qualifications

Required qualifications:(Remote Opportunity)

• Bachelor's degree required. Scientific or engineering field preferred.

• 5+ years of medical device regulatory affairs experience.

• Must have authored 510(k) submissions

• Must have knowledge of U.S. FDA regulations and standards

• 3+ years of experience interacting with FDA and/or other regulatory agencies

• Experience with devices containing software is strongly preferred.

• Must work well in team environments

• Must demonstrate leadership skills in team setting.

• Proven analytical abilities

• Solid understanding of manufacturing and change control, and an awareness of regulatory trends

Additional Information

To know more on this position or to schedule an interview, please contact;

Ujjwal Mane

973-805-7557

ujjwal.mane[@]collabera.com