Regulatory Affairs Specialist, MedTech – Global Submissions

BD; California; Sur place; USD 136 000 - 217 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) with company match

Paid time off

Résumé du poste

BD is a leading global medical technology company focused on advancing the world of health. The Staff Regulatory Affairs Specialist will drive regulatory strategy and global submissions for PreAnalytiX and Lab Specimen Management products across US, EU, and ROW markets.

You will lead regulatory activities from early development to product launches, assess changes, and support 510(k) submissions and CE marking, collaborating with cross-functional teams to ensure compliance and timely market

Qualifications

• BS in a scientific/health/technical field.
• 5+ years regulatory affairs in medical devices/IVD.
• Proficient technical writing and submissions.
• Experience with cross-functional collaboration.
• Proficient in MS Word, Excel, PowerPoint.

Responsabilités

• Coordinate and prepare premarket submissions (510(k), De Novo, PMA) and liaise with FDA.
• Assess need for 510(k) modifications and provide rationale.
• Prepare technical files for CE marking with input from R&D, QA, Manufacturing.
• Lead regulatory strategy development for lifecycle changes and NOC assessments.
• Register devices worldwide and support global regulatory submissions.

Connaissances

Regulatory affairs

Technical writing

Cross-functional teamwork

MS Office

Formation

B.S. in science/health/engineering

Outils

FDA submissions process

Description du poste

BD is a leading global medical technology company focused on advancing the world of health. The Staff Regulatory Affairs Specialist will drive regulatory strategy and global submissions for PreAnalytiX and Lab Specimen Management products across US, EU, and ROW markets.

You will lead regulatory activities from early development to product launches, assess changes, and support 510(k) submissions and CE marking, collaborating with cross-functional teams to ensure compliance and timely market