The Associate Regulatory Consultant is a critical member of the Alira Health project team. Associates work closely with Managers and senior executives and work with clients to guide, write and streamline regulatory projects. The individual 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.
ESSENTIAL JOB FUNCTIONS
- Provide expertise and guidance in interpreting regulations and agency guidelines.
- Provide Regulatory support for processes regarding labeling activities.
- 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
- Provide regulatory strategic support and direction to client programs and initiatives.
- Draft regulatory strategies in line with client business objectives and regulations
- Draft Submissions of 510ks, PMA’s, RFDs and IDE’s and interface with FDA
- Design and implement regulatory strategies to obtain, maintain and extend product registrations for new medical device and combination product portfolios.
- Oversee the development and submission of regulatory filings to FDA and EU
- 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, AND ABILITIES
- BS/BA from an undergraduate program in a scientific discipline
- 5-7 years’ experience in a regulatory role within medical device or biotechnology sectors
- Experience writing 510ks and other regulatory submissions
- Knowledge of appropriate regulations within your specific sector
- Knowledge of FDA regulations
- Knowledge of EU MDR regulations a plus
- 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
- Self-starter who thrives in a collaborative, yet less structured team environment
- We will not sponsor applicants for work visas