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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

THE SENIOR REGULATORY AFFAIRS MANAGER ROLE

The Senior Regulatory Affairs Manager is a critical member of the Alira Health project team. The Senior Regulatory Affairs Manager will work closely with Managers and VP and work with clients to guide, write and streamline regulatory projects. The Senior Regulatory Affairs Manager 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 focus of the Senior Regulatory Affairs Manager will be to work on EU and FDA-related projects. Expertise in both markets is not a must, but it is preferred if the Senior Regulatory Affairs Manager is willing to continue learning in case of lower expertise in one of both markets before mentioned.

ESSENTIAL JOB FUNCTIONS

• Be hands-on on planning, organizing, executing, writing and delivering projects.

• 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 EU/NB-related submissions: Roadmaps, Gap Analysis, Product categorization, Technical Documentation compilation, Response to non-conformities, etc.

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

• Intervention in prospective calls with clients and participation in proposals preparations.

• 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

• 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.

• 7+ years’ experience in a regulatory role within medical device sector.

• Knowledge of appropriate regulations within the specific sector.

• Previous experience in consulting will be favorably valued.

• Knowledge of FDA procedures.

• Knowledge of MDR and IVDR.

• 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.

• The role for Manager/Sr Manager/Director requires ability to work hands-on on the execution and delivery of the projects.

• The role for Director requires ability to work hands-on on the execution and delivery of the projects.

• 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 up to 30 lbs.

Languages

English

Education

Bachelor of Science (BS)

Contract Type

Regular