3+ years of regulatory experience in the medical device industry
Proven record of successful regulatory submissions, preferably Class III
Strong oral and written communication skills
Ability to exercise independent judgment and decision-making
Detail-oriented with strong organizational skills
Strong interpersonal skills and accountability for deliverables
Experience in fast-paced environments with adaptability to changing priorities
Responsibilities
Prepare and maintain regulatory submissions for complex Class III devices
Support compliance with regulatory requirements through documentation and project management
Assist in preparing international regulatory documents, including EU Technical Files
Manage vigilance reporting for the US and international markets
Liaise with Quality and Engineering teams regarding FDA and EU regulations
Support FDA, Notified Body, and internal audits as needed
Create or revise departmental procedures to align with regulatory changes
Benefits
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental and Vision insurance
Healthcare and Dependent Care Flexible Spending Accounts
Short and Long Term Disability coverage
401K Plan
Pet insurance
Employee Stock Purchase Plan
Full Job Description
Job Description:
POSITION SUMMARY:
Due to rapid growth, we are currently looking for a Specialist, Regulatory Affairs, based in our Andover, MA headquarters, to join us as we revolutionize this cutting-edge medical field. If you are looking for a forward-thinking and fast-paced entrepreneurial culture, you thrive on challenges and are interested in furthering your career, we want to talk to you!
ESSENTIAL TASK AND DUTIES INCLUDE:
Prepare and maintain regulatory submissions and registrations of complex Class III devices in the US and in international markets
Maintain documentation and perform project management tasks to support compliance with applicable regulatory requirements in the US and worldwide.
Assist with the preparation of international regulatory documents, including EU Technical Files and documentation related to EU MDR certification
Assist with vigilance reporting in the US and around the world
Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations
Participate and provide support for FDA, Notified Body and internal audits as required
Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules.
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards
Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements as needed
BACKGROUND AND QUALIFICATIONS:
3+ years regulatory experience in the medical device industry with a proven record of successful regulatory submissions (Class III experience preferred but not required)
Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
Ability to utilize effective analytical and decision making skills
Ability to act independently to determine methods and procedures
Must be detail oriented with strong organizational skills
Must have strong interpersonal skills with willingness to be held accountable for deliverables
Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities
EDUCATION:
Bachelor's in Engineering, Life or Biological Sciences, or related field, Master's Degree a plus
Every Organ Wasted is a Life Not Saved.
Maximize your potential at TransMedics, Inc.
www.TransMedics.com
#LI-Hybrid
Employee Benefit:
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
