Description

The Regulatory Affairs Coordinator will undertake a variety of administrative tasks supporting regulatory projects. Responsibilities include but are not limited to document formatting, document generation, document storage coordination, and shipping of regulatory submissions. The role requires managing multiple deliverables, including project planning, action plan creation, tracking, escalation communication, stakeholder management, and daily management. This position involves cross-functional collaboration on specific projects, especially with R&D and QA teams.

Company Culture and Environment

The company emphasizes a fast-paced and constantly changing environment where independent work is valued. Employees are encouraged to be self-starters and results-oriented, fostering a culture of accountability and excellence.

Career Growth and Development Opportunities

While specific career advancement opportunities are not explicitly mentioned, the regulatory affairs field typically offers pathways for growth within the industry, especially for candidates with relevant experience and skills.

Detailed Benefits and Perks

• Hybrid work model - in-office three days per week
• Limited travel expectations (<10%)

Compensation and Benefits

• Competitive compensation based on experience
• Health and wellness benefits (details not specified)

Why you should apply for this position today

This role offers a unique opportunity to contribute to important regulatory processes within the healthcare field. By joining a dynamic team dedicated to quality and compliance, you can make a meaningful impact in the industry while furthering your career in regulatory affairs.

Skills

• Proficient in MS Word and MS Excel
• Strong independent worker capable of managing tasks in a fast-paced environment
• Excellent organizational and time management skills
• Strong attention to detail
• Excellent interpersonal and communication skills

Responsibilities

• Complete administrative tasks for regulatory project support
• Manage multiple deliverables, including project planning and action plans
• Track project progress and communicate escalations as necessary
• Collaborate with cross-functional teams on specific projects

Qualifications

• 1-3 years of regulatory affairs experience required
• High School Diploma or equivalent required
• Associate or Bachelor’s degree preferred in science or related field
• IVD Regulatory Affairs or Quality Assurance experience highly desirable

Education Requirements

• High School Diploma or equivalent required
• Associate or Bachelor’s degree preferred

Education Requirements Credential Category

• High School Diploma, Associate’s Degree or Bachelor’s Degree in science or related field

Experience Requirements

• 1-3 years of experience in regulatory affairs
• Relevant experience in IVD Regulatory Affairs or Quality Assurance is beneficial

Why work in Danvers, MA

Danvers, MA offers a suburban environment with access to a rich history and vibrant community. The location provides a blend of peaceful living and proximity to urban amenities, making it an attractive place for professional and personal growth. The area is well-connected and provides numerous recreational activities, dining options, and educational institutions.