Job Overview
The Regulatory Affairs Manager provides regulatory leadership to the Company, ensuring that Sonablate Corp. continues to meet its Quality Policy and Objectives. This role involves the development and implementation of global processes across multiple locations and stakeholders from Manufacturing Operations to Clinical Operations. The Regulatory Affairs Manager is a driven and motivated individual who has strong experiences of self-motivation in complex situations. The role is cross-functional as well as fast paced and requires a strong leader willing to wear multiple hats. If you are a highly motivated individual with a passion for regulatory affairs and a desire to make a difference, we encourage you to apply.

Duties and Responsibilities

• Develop and implement regulatory strategies to support domestic and global expansion efforts.
• Stay current on new and emerging compliance procedures and regulatory enforcement trends/actions.
• Track regulatory updates with emerging global changes and new international regulatory standards.
• Manage and participate in the compilation of documents as needed for product registrations, licensing, and notifications to be submitted to regulatory authorities, notified bodies, authorized representatives, and MDSAP countries.
• Research new standards, regulations, and regulatory submission requirements for all markets
• Support business development team, including responding to document requests.
• Provide Regulatory feedback and guidance throughout the development cycle. Prepare regulatory non-filing justifications, as required.
• Review new and modified devices for fulfillment of regulatory premarket obligations and identification of appropriate standards for electrical and mechanical safety.
• Manage Post Market Surveillance strategy development, implementation, and execution. Lead a cross-functional team to develop and implement PMCF and Clinical Evaluation activities.
• Execute and maintain all procedures related to vigilance and reporting requirements, including leading investigations, filling out and submitting reports through regulatory channels, as well as providing a regulatory review of service bulletins, advisory notices, and recalls, etc.
• Ensure that reporting requirements regarding new and modified device requirements are met.
• Maintain appropriate domestic and international registrations and product listings, including renewals and ensuring that regulatory and notified bodies databases are updated and maintained with correct contact information
• Participate in Quality functions as needed, including investigations, CAPAs, feedback/complaint handling, and auditing. Internal Audit experience or certification is a plus.
• Manage relationships with notified bodies, authorized representatives/sponsors/etc.
• Review distribution, authorized representative, and Notified Body contracts.

Other

• Provide assistance as needed with corporate regulatory compliance.
• Responsible for all regulatory procedures, including all RA review and RA input in cross-functional procedures
• Provide regulatory review in the context of marketing requirements, including advertising, language, claims, and branding

Qualifications/Specifications

• Bachelor’s Degree, required.
• 5 years (7 preferred) experience in medical device industry required. Experience with Class II devices preferred.
• General understanding of ICH, Good Clinical Practices, FDA’s Quality System Regulation, ISO 13485, MDSAP, JPAL, CMDR, healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
• Experience with EU MDD and EU MDR is required.
• Self-motivated with a proactive attitude and the ability to work independently.
• Strong problem-solving and decision-making skills.
• Strong interpersonal and written and oral communication skills. Open, honest communication is a must.
• Strong organizational skills.
• Computer proficiency (SharePoint programs).
• Minimal travel required.

Job Type: Full-time

Pay: $110,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee stock purchase plan
• Health insurance
• Health savings account
• Life insurance
• Paid parental leave
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Ability to Relocate:

• Indianapolis, IN 46226: Relocate before starting work (Required)

Work Location: In person