Senior Consultant – Regulatory Affairs

Avania is Hiring – Senior Consultant – Regulatory Affairs and Advisory Services
Avania is adding to our dynamic, multi-disciplinary Regulatory and Advisory Services team. We are looking for a Senior Consultant to support Avania’s existing regulatory and quality as a service business deliveries and operational expansion for FDA/Health Canada on regulatory and clinical strategy. This role focuses on regulatory approaches for both FDA IDE/510(k)/PMA pathways and Health Canada MDEL processes while ensuring ISO 14155:2020 compliance for clinical and related regulatory activities.

Role of Senior Consultant: General Responsibilities
Independently performs project work with strategic input from Principal Consultants and/or Management.

Provides expert advice to clients based on in-depth industry knowledge.

Role of Senior Consultant: Project Management
Oversee and manage client projects from initiation to completion, ensuring that all deliverables and project workstreams are completed on time, on budget, and to the client’s satisfaction.

Responsibilities include defining project scope, setting milestones, coordinating cross-functional teams, monitoring progress, mitigating risks, and maintaining budget control.

Contribute to monthly project forecasting.

Role of Senior Consultant: Client Management
Act as the primary point of contact for clients, establishing trust with key client stakeholders.

Understand client’s expectations and align expectations with Avania’s capabilities and the proposed scope of work.

Act as initial point of contact for client concerns or issues that may arise, escalating to management if needed.

Role of Senior Consultant: Business Development
Participate in business development activities including drafting proposals and defining project scope.

Qualifications and Experience
We are looking for a Senior Consultant to support Avania’s existing regulatory and quality as a service business deliveries and operational expansion for FDA/Health Canada on regulatory and clinical strategy. The focus is on regulatory approaches for both FDA IDE/510(k)/PMA pathways and Health Canada MDEL processes while ensuring ISO 14155:2020 compliance for clinical and related regulatory activities.

Experience working as a regulatory consultant or within a company developing a novel medical device is highly desirable.

What We Offer
The opportunity to work in an innovative, fast-growing and rewarding industry.

A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties.

Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities.

Competitive compensation and benefits package (details shared during the interview process).

Some roles offer the opportunities for travel.

Ask us about our hybrid and fully remote work opportunities.

We look forward to receiving your application!

When you need to advance your career, it takes Avania!

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