Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Details
Posted : 14-May-24
Location : Covington, Georgia
Type : Full Time
Categories :
Medical Device Quality / Risk Management Submission & Registration Worldwide Regulatory Affairs
Required Education : 4 Year Degree
4 Year Degree
Internal Number : R-488322
Job Description Summary
As Regulatory Affairs Specialist II, you will be responsible for the implementation of strategies including domestic and international submissions and other product project team supports.
This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is Covington, Georgia.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat.
It takes the imagination and passion of all of us from design and engineering to the manufacturing and marketing of our billions of MedTech products per year to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self.
Become a maker of possible with us.
Key responsibilities will include :
Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
Prepare and audit 510(k)s, IDEs, PMA and / or international submissions as required
Provide technical collaboration with FDA and international reviewers and respond to questions
Provide timely review and approval of product labeling and marketing claims for regulatory compliance
Prepare and update STED technical files for CE marking activities and notified body interaction
May direct Project Team associates
About you : To be successful in this role, you require :
Must have knowledge of U.S. and European medical device regulations
Must have excellent written and verbal communication skills
Must be self-motivated, work independently and have the ability to take ownership of responsibilities