Hybrid Regulatory Affairs Specialist - Submissions

Anika; Bedford (MA); Híbrido; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Anika is seeking a Regulatory Affairs Specialist II to support regulatory submissions, authority interactions, and post-approval activities. The role requires preparing documentation, maintaining compliance, and guiding cross-functional teams through regulatory processes.

The position emphasizes attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment, with hybrid work based in Bedford, MA.

Formación

• Bachelor’s degree in Life Sciences or related field, or equivalent experience.
• 2+ years of regulatory affairs experience.
• Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.
• General understanding of global and U.S. regulatory processes.
• Excellent written and verbal communication and strong project management skills, with ability to manage multiple priorities.

Responsabilidades

• Prepares regulatory documentation packages for review and submission to regulatory agencies and commercial partners to achieve departmental and organizational objectives.
• Prepares, submits, and archives 510(k)s, Letters to File, EU MDR technical documentation, and Change Notifications.
• Responds to FDA and Notified Body submission queries and supports regulatory authority interactions.
• Provides regulatory support for post-launch business maintenance activities under guidance of Senior Regulatory Affairs personnel.
• Reviews labeling and engineering changes for compliance with regulatory filings.
• Maintains current knowledge of FDA, ICH, and international regulatory guidelines and requirements.
• Collaborates with cross-functional teams and commercial partners to support regulatory submissions, product changes, and post-approval activities.
• Performs other duties and projects as assigned.

Conocimientos

Regulatory affairs

510(k) submissions

EU MDR experience

Project management

Attention to detail

Cross-functional collaboration

Educación

Bachelor’s degree in Life Sciences or related field

Descripción del empleo

Anika is seeking a Regulatory Affairs Specialist II to support regulatory submissions, authority interactions, and post-approval activities. The role requires preparing documentation, maintaining compliance, and guiding cross-functional teams through regulatory processes.

The position emphasizes attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment, with hybrid work based in Bedford, MA.