Regulatory Affairs Coordinator II
In-Office, Covington, GA
- 求人ID
- R-555957
- Category
- Regulatory Affairs
- Location
- Covington, ジョージア州
We are the people who give possibilities purpose
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.
Job Description
Responsibilities:
- Coordinates the Regulatory Change Management process by evaluating requests, compiling information, and summarizing responses. Administers regulatory team systems and uploads documentation to Electronic Document Management System (EDMS), ensuring all regulatory materials are properly maintained and accessible.
- Works closely with Regulatory Affairs Specialists to prepare critical regulatory documentation including registrations, Summary Technical Electronic Documentation (STEDs), and dossiers. Manages extensive word processing needs including FDA documents, certificates, status reports, and presentations.
- Coordinates and responds to external requests for product data, information, surveys, and questionnaires from customers, serving as a key liaison between the organization and its clients for regulatory matters.
- Takes responsibility for updating Standard Operating Procedures (SOPs), Work Instructions (WIs), and policies as needed, ensuring the department maintains compliance with current regulatory requirements and internal standards.
- Handles departmental administrative functions including ordering supplies, creating purchase requisitions using applicable systems, and managing correspondence to support the regulatory affairs team's operational needs.
Minimum Requirements:
- High School diploma or equivalent experience in a regulated environment
- 1-3 Years Regulatory Affairs or Quality Assurance experience with medical technology companies
- Proficient in using Microsoft Word, Access, Excel and Outlook
Preferred Requirements:
- Bachelor Degree, BS
- Strong communication and project management skills
- Must be able to balance multiple tasks
- Attention to details
- Knowledge of Medical Device Quality Systems and Good Documentation Practices
- Able to be Notary Public
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
#earlycareer
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
.
Primary Work Location
USA GA - Covington BMDAdditional Locations
Work Shift
US BD 1st Shift 8am-430pm (United States of America)
See the area you’ll be working in.
Explore the area-
BDについて -
キャリア分野 -
BDの拠点 -
応募者向けFAQ -
ブログ -
コーポレート部門でのキャリア -
BDにおける候補者プライバシー通知 -
エンジニアリングおよび研究開発部門のキャリア -
製造部門のキャリア -
メディカルアフェアーズおよび薬事部門のキャリア -
就職詐欺には注意 -
BDで築くあなたのキャリア -
インクルージョンとエンゲージメント -
私たちのカルチャー -
営業部門のキャリア -
フィールドサービスのキャリア -
AIと求職活動 -
新卒・若手人材向けキャリア -
BDの面接に向けた準備方法 -
BDにおけるプライバシーに関するお知らせ -
品質部門のキャリア -
マーケティング部門のキャリア -
応募書類を目に留めてもらうためのポイント
求人アラートに登録する
スキルや希望勤務地に合ったポジションの募集開始時に通知を受け取れるよう、求人アラートを作成しましょう
関連コンテンツ
-
キャリア分野
多様なキャリアパスを探索し、あなたのスキル、情熱、目標に合った仕事を見つけてください。 -
BDの拠点
地域で培った専門性をグローバルな影響力へーあなたの活躍の場所を見つけましょう。 -
応募者向けFAQ
よくあるご質問への明確な回答を得て、自信を持ってプロセスの各ステップを進めていきましょう。 -
ブログ
あなたの成長にインスピレーションを与え、キャリアの歩みをサポートするストーリー、カルチャー、役立つヒントをご紹介します。 -
BDで築くあなたのキャリア
私たちは、キャリアは単なる職務内容以上のものに基づいて築かれるべきだと考えています。 BDでは、キャリアを人生の旅路と捉えています。どの段階においても、成長し、リーダーシップを発揮し、変化をもたらす真の機会があります。 これからキャリアをスタートさせる方にも、次のステップを目指す方にも、BDは一人ひとりに合ったリソース、グローバルなプログラム、そして前進を大切にする企業文化を通じて、あなたの成長を支援します。