Senior Director of Regulatory Affairs

Company Overview IE is a Consumer Healthcare Technology and Pharmaceutical Launch Partner dedicated to accelerating safe access to life-changing treatments.

Our notable roster of clients comprises heavyweights in the industry like AstraZeneca, Petros Pharma, Cadence Health, Horizon Therapeutics, and United Therapeutics.

Position Overview We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs   to join our team working in SaMD.

As the Regulatory leader, you will be responsible for driving the regulatory strategy and execution of innovative products in the Software as a Medical Device space.

You will have the opportunity to define regulatory requirements and policies that affect product requirements, creating product roadmaps, and prioritizing features based on client feedback and business objectives.

The primary duties associated with this role are :

• Serve as client facing, regulatory lead to bring SAMD products to the US market with FDA approval.
• Provide regulatory expertise, guidance, and direction, inclusive of potential risks and strategic opportunities, to regulatory affairs and cross functional leadership.
• Evaluate proposed product modifications for regulatory impact and completing regulatory assessments.
• Driving regulatory compliance for successful FDA 510(k) submissions.
• Supporting RA specialists in preparation and submission of 510(k)s, including any follow up and Note to Files.
• Supporting Business Unit regulatory affairs teams to interact with FDA in support of ACNU clearance activities.
• Overseeing QA / RA team to provide support for ensuring company compliance with all applicable quality, regulatory, & statutory requirements.
• Serving as Management Representative leading and promoting company initiatives in support of Idea Evolver’s Quality Policy and Objectives through continuous improvement of the Quality Management System (QMS) and associated records.
• Overseeing CAPA, Change Management, Internal and External Audits, Management Review & Post-Market Surveillance needs.
• Ensuring the organization is meeting regulatory and quality objectives.
• Responsible for ensuring compliance to Design Control & SDLC process requirements at a project level.
• Serving as the main contact between Idea Evolver and customer to support regulatory submissions, communications with the FDA and supporting audits.
• Maintaining current knowledge of the development and changes to applicable laws, regulations and industry standards for the US and assist in the dissemination of this information.
• Ensuring cross-functional teams receive communication regarding project milestones to support their daily work.
• Interfacing with appropriate internal and external resources to ensure on-time delivery for project and accurately communicate project risks, impacts and mitigation.
• Leading teams in preparation for Phase Gate Reviews and decisions.

Qualifications include :

Compensation and Benefits :