Regulatory Affairs Manager Job at HireResources, Carlsbad, CA

  • HireResources
  • Carlsbad, CA

Job Description

This position is responsible for implementing and managing the Companys regulatory affairs function:\
Oversee and maintain ongoing relationships with regulatory authorities\
Responsibilities include the development, implementation, and management of the Companys compliance functions\
Responsible for ensuring general compliance with Federal and State regulations applicable to the manufacture and distribution of medical devices, including facility licensure and product registration\
Formulates and establishes clear objectives and work plans -reviews progress against targets and creates countermeasures, where necessary, to achieve success\
Develops RA Strategy and may also be responsible for managing a team of RA specialists\
Communications with regulatory bodies on significant matters, including formal responses to regulators on submissions, with supervision\
Communicates regulatory requirements to functional leaders, exercises judgment on when to escalate regulatory queries for managerial input \
Create and manage domestic and global product submissions (e.g. EU Technical Files, International Dossiers, 510ks), including CFGs, Certificates of Free Trade, and legalization of regulatory documentation\
Manage internal processes to meet FDA, EU, Health Canada, Notified Body, and other regulatory authority requirements\
Complete regulatory assessments for new products or product modifications and develop regulatory strategies for their respective product launches domestically and internationally\
Support and provide regulatory guidance on pre-production and design releases of new product development for domestic and international distribution\
Maintain current state and federal registrations (wholesale distribution)\
Review and approve labeling and promotional materials\
Manage regulatory compliance activities such as HHEs, adverse event reporting, and recall execution and reporting\
Monitor and communicate changes to regulations, legislation, guidance documents, and policy to determine the impact on the organization\
Oversee government inspection activities, including inspectional observations, as well as corrective action plans\
Train and develop direct reports to ensure successful TSM growth within the organization
Employment Type: Full-Time

Job Tags

Full time,

Similar Jobs


Barista - Simmons University - Coffee Shops Job at Aramark

 ...unlimited career growth and opportunities! Were hiring full-time Baristas to be the perfect blend to our team. Youll prepare specialty...  ...customers while anticipating their needs Prepare and serve coffees, teas, specialty beverages per brand standards Prepares and... 

Keller Montessori School

Montessori Lead Teacher Job at Keller Montessori School

Our school is growing, and we are in need of some help! This posting is for a Montessori Lead Class Teacher. Supervising a Montessori group of children (3-6 years old) requires experience in teaching Montessori. Why would you want to work at Keller Montessori School? We...

The University of Mississippi

American Sign Language Interpreting Instructor Job at The University of Mississippi Position Description The Department of Communication Sciences and Disorders is seeking applications for an American Sign Language/Interpreting Instructor. This is a nine-month, non-tenure track position at the rank of instructor. Applicants must have an MA degree... 

Weatherby Healthcare

A Dermatologist Is Wanted for Locums Help in IN Job at Weatherby Healthcare

A Dermatologist Is Wanted for Locums Help in IN Employer Location Bloomington, Indiana Salary Join our team! Closing date Sep 11, 2024 Specialty Position Type You need to sign in or create an account to save a job.

Kennedy-Donovan Center

Spanish Interpreter (Part-Time) Job at Kennedy-Donovan Center

 ...every individual and family thrives, no matter the circumstances. About the Role: KDC is seeking a part-time, in-person Spanish Interpreter who will assist Early Intervention Specialists by providing written and verbal interpretation services. The ideal candidate...