Principal Regulatory Affairs Specialist

Overview

As a leader in image guidance solutions, IMRIS, Deerfield Imaging provides optimized, fully integrated image-guided therapy environments that address the important needs of patients, clinicians, and hospitals by delivering timely MRI and imaging data to clinicians for use during surgical or interventional procedures. The IMRIS Surgical Theatre enables intraoperative imaging directly within operating rooms. The Company also designs and manufactures proprietary head fixation devices, imaging coils and OR tables for use in this unique and multifunctional intraoperative environment. It is estimated that over 70,000 patients have benefited from lifesaving or life-extending procedures performed in an IMRIS Surgical Theatre. IMRIS will continue to integrate new intraoperative imaging technologies and shape the future of neurosurgery in operating rooms worldwide.

We are currently searching for a Principal Regulatory Affairs Specialist to join our Regulatory Affairs Team. This role can be performed both on-site and remotely as necessary, but is based in the Greater Twin Cities area at our Chaska, MN headquarters. Please note: There is no relocation offered for this position.

The Principal Regulatory Affairs Specialist is a member of the quality and regulatory team that will drive regulatory direction and provide strategic inputs to cross functional members. This Principal role will lead and provide key contributions to IMRIS design enhancements, new product development, compliance, and regulatory strategy including supporting product registrations and post-market activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Acts as core member on new product development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinates team inputs for submissions.
• Work with project teams to complete regulatory evaluations, develop strategies and execute project plans to support all regulatory aspects of new product development and product modifications.
• Provide hands-on regulatory leadership for new product clearance/approvals, renewals for existing products, and preparation of submissions for US and OUS countries.
• Defines US and OUS regulatory requirements necessary for regulatory clearance/approval of assigned products.
• Maintains regulatory documentation to ensure availability for audits and submission packages.
• Rigorous documentation for all phases of regulatory submissions, including requirements, documentation gathering, submission writing, approvals, renewals, and change orders.
• Maintain and understand current/evolving submission requirements for US and OUS regions applicable to IMRIS.
• Advise and train project teams regarding new, existing or changing regulatory requirements.
• Actively conduct Regulatory Intelligence/mapping to stay current on evolving regulatory trends relevant to IMRIS s products and implement appropriate actions.
• Leads the generation and compilation of technical documentation for EU MDR compliance.
• Lead process improvement initiatives for quality and regulatory systems to maintain and/or improve compliance and efficiency.
• Support Quality audits and interactions with appropriate regulatory bodies. May be part of external interactions with regulators and support cross-functional teams to deliver appropriate information and responses.
• Create and maintain regulatory agreements and contracts.
• Manage and maintain international economic operator relationships, ensuring compliance with geography-specific requirements.
• Review marketing materials and customer sales proposals for compliance to applicable regulatory requirements.
• Provide regulatory input and guidance for Post Market Surveillance activities and Clinical Evaluation Reports.
• Support various Regulatory compliance activities and projects.

SUPERVISION RECEIVED AND EXERCISED

• Reports to the Regulatory Affairs Manager

KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS

• Knowledge of standards and directives for applicable jurisdictions in scope of the IMRIS QMS to include:
  • European MDD 93/42/EEC and EU MDR
  • Canadian Medical Device Regulations (SOR/98-282)
  • MDSAP (Medical Device Single Audit Program)
  • ISO 13485
  • Japanese QMS Ordinance (MHLW MO 169)
  • Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
  • US FDA Quality System Regulation, MDR, Recall
  • CFDA (China) Quality System regulations
• B.Sc. in a related field, an advanced degree in engineering, regulatory affairs or a related field
• Minimum 6 years experience in Medical Device Regulatory Affairs, or minimum 3 years Medical Device Regulatory Affairs experience and 3 or more years of experience in a related discipline (e.g., R&D, Quality, Medical Affairs, Biocompatibility)
• Experience advising senior leadership and applying pre/post market regulations
• Direct experience with FDA inspections, ISO 13485 audits, and experience communicating with government authorities
• Understanding of product development process and design controls
• Experience authoring and submitting FDA 510(k) submissions, EU MDR submissions and other ROW geography registrations
• Experience with regulatory requirements for medical device software and cybersecurity is an asset
• Ability to function independently
• RAPS certifications are an asset
• Understanding of technical drawings and schematics

Visit our website: www.imris.com

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IMRIS is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status.