Regulatory Affairs Consultant/Senior Consultant

ABOUT ALIRA HEALTH At Alira Health, our mission is to enable healthcare transformation.

Our team collaborates fully to understand every aspect of each client’s organization from concept ideation to commercial realization, from innovation to implementation.

We support our clients with a full spectrum of patient-centric data and tech enabled services including Transaction Advisory, Management Consulting, Real-World Evidence, Advanced Analytics, Patient Engagement, Product Development, Regulatory, Clinical and Market Access.

Our clients are global, and so are we.

Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle.

We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.

THE CONSULTANT/SENIOR CONSULTANT, REGULATORY AFFAIRS The Consultant/Senior Consultant, Regulatory Affairs is a critical member of the Alira Health project team.

The Consultant/Senior Consultant will work closely with Managers and senior executives and work with clients to guide, write and streamline regulatory projects.

The Consultant/Senior Consultant will help to set direction for clients in the coordination, execution, guidance and implementation of regulatory programs, requirements and compliance activities.

The individual will be a key resource for all regulatory activities.

The main focus of the Consultant/Senior Consultant will be to work on FDA-related projects.

It is preferred if the Consultant/Senior Consultant is willing to either learn or work on EU Regulatory Projects in the long run.

ESSENTIAL JOB FUNCTIONS
• Provide expertise and guidance in interpreting regulations and agency guidelines.

• Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which the clients’ products are regulated around the world.

• Plan, manage, prepare and submit FDA-related submissions: RFD, Pre-Submissions, 510(k), De Novo, PMA, IDE, BDD, etc.

• Provide, as needed, regulatory strategic support and direction to client programs and initiatives.

• Design and implement regulatory strategies to obtain, maintain and extend product registrations for new device/combination product/companion diagnostic portfolios.

• Oversee the development and submission of regulatory filings to FDA, and EU (at some point)
• Serve as liaison with regulatory agencies.

• Lead core regulatory activities to ensure effective agency interactions that are consistent with clients’ regulatory strategies.

• Provide regulatory guidance and input to clients.

• Provide regulatory operations and electronic submissions support.

• Performs additional duties as assigned.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
• BS/BA from a top undergraduate program in a scientific discipline.

• 3 -6 years’ experience in a regulatory role within medical device sector.

• Knowledge of appropriate regulations within the specific sector.

• Knowledge of FDA procedures.

If the Consultant or Senior Consultant has knowledge on EU MDR and IVDR, it will be an added value.

• Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges.

• Demonstrated ability to communicate complex information and analyses to a variety of audiences.

• Strong command of English, both written and verbal.

• Excellent communication and interpersonal skills with client service orientation.

• Advanced skills in MS Office Suite, particularly Word.

• Thrives in collaborative, yet less structured team environment.

• We will not sponsor work visas.

WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use.

Occasional lifting of weight up to 30 lbs.

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