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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