Regulatory Affairs Manager

The Regulatory Affairs Manager C2Dx is a leadership position contributing significantly to the Quality Assurance and Regulatory team. In this role, you will be a critical team member contributing to the execution of the company strategy and Quality Management System (QMS) for an evolving medical device company. This role will provide Regulatory Affairs leadership with significant time spent managing product regulatory strategy, licensing, market authorization, and registration tasks and documents and maintaining regulatory filing documents required by various countries and jurisdictions. You will be expected to work alongside cross-functional management teams and support our products, services, and Quality System.

Duties and responsibilities

To be successful in this role, an individual must be able to perform the following satisfactorily; other duties may be assigned.

• Understand and perform duties and responsibilities according to the C2Dx QMS
• Lead and execute regulatory strategies to protect and enhance profitability
• Develop, implement, maintain, and improve regulatory processes ensuring compliance with all applicable regulatory requirements
• Provide regulatory leadership on new product registrations, modified/enhanced products, transferred products, and acquisition activities
• Perform and/or direct coordination and preparation/submission of any/all documents for regulatory submissions, inspection responses, and regulatory agency notifications when required
• Provide direction and coaching to specialists to meet regulatory requirements as scheduled and resolve technical or operational issues
• Collaborate with external regulatory authorities, competent authorities, authorized representatives/sponsors, importers/distributors, and notified bodies partnering with cross-functional stakeholders to ensure alignment and effective execution of regulatory strategy to achieve business objectives
• Lead interactions with regulatory agencies as part of strategy development and support of regulatory application and document reviews
• Provide guidance to all team members on regulatory requirements for planning and contingencies ensuring compliance with all applicable regulations
• Provide status reports to executive management
• Support internal quality and external regulatory authority or notified body audits as required
• Perform regulatory review and approval of product and manufacturing changes for compliance with applicable regulations when required
• Continually provide and contribute towards company and process improvements to the C2Dx QMS

Qualifications

• Bachelor's degree in an engineering, healthcare, or scientific field with 3-5 years of relevant experience is required
• Prior experience within regulatory affairs in healthcare, medical device, or pharmaceutical industry is required
• Prior experience in managing regulatory projects with multi-national regulations and agencies experience is preferred
• Master’s degree or relevant certifications is a plus

Working conditions

This is a Salaried, exempt position that will require occasional evening work, correspondence with internal and external stakeholders outside of normal working hours

Must be eligible to work in the U.S. and provide proper documentation within 3 days of employment

Must successfully pass background screening and drug screening

Physical requirements

Travel not to exceed 20%

Lifting - may need to occasionally push, pull, or lift 25-50 lbs

Frequent walking, standing, or sitting for extended periods