remote career opportunities with a global impact! BD is seeking Regulatory Affairs Specialists with Bachelor’s degrees in Life Sciences or Engineering for work from home positions across multiple locations. Join us in advancing the world of health™ from the comfort of your home.
Job Description:
Be part of BD's regulatory team, contributing to maintaining high standards in regulatory compliance for medical devices. This role involves meticulous attention to detail, effective communication, and a continuous learning mindset. You’ll apply your expertise in FDA, Canadian, and ISO/MDD regulations to drive health advancements worldwide.
Key responsibilities:
- Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.
- Collect and organize labeling related documentation for core team member review.
- Perform gap analysis to support labeling projects.
- Review label specifications for adherence to labeling procedure requirements.
- Compile and categorize cross-functional feedback as an output to labeling review requests.
- Assist in regulatory activities related to US and OUS labeling remediation.
- Review protocols, reports, and journal articles to ensure collection of appropriate data to support promotional materials.
- Help draft and route standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
- Remain current on standards and regulations affecting advertising, promotion, and labeling and communicate the impact cross-functionally.
- Perform other duties and assignments as required.
- Support activities and attend team meetings outside of standard workings hours.
Professional Skills & Key Competencies
- Excellent verbal and written communication skills.
- Demonstrated ability to analyze, interpret, and review scientific, technical, and regulatory literature and documents.
- Excellent attention to details.
- Flexible and adaptable to fulfill business priorities.
- Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).
- Manages time efficiently.
Minimum Qualifications:
- Bachelor’s degree in Life Sciences or Engineering.
- One (1) to three (3) years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry.
- Excellent interpersonal, communication and analytical skills.
Desired/Additional Skills & Knowledge:
- Familiarity and background with advertising, promotion, and labeling in the medical device industry.
Certifications
Qualifications:
- Essential: Bachelor’s degree in Life Sciences or Engineering.
- Experience: 1-3 years in Regulatory Affairs in medical device/pharmaceutical industries.
- Desirable Skills: Familiarity with advertising, promotion, and labeling in the medical device industry; RAPS RAC certification.
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Work from Home Regulatory Affairs Specialist Vacancies[/caption]
Why Join BD: At BD, you’ll collaborate with inspiring leaders and colleagues in a growth-centered culture. Shape the future of health while leaving a lasting impact.
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