Mdr Project Coordinator Jobs

Assist Global MDR Submission Management in the successful identification and resolution of quality issues associated with complaints.

Bachelor of Science degree with a minimum of 1-3 years medical device experience

Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.

Complaint Handling / Customer Service experience in the Medical Device / Pharmaceutical required.

Effective communication skills - both written and verbal English language.

Ability to effectively prioritize and manage workload.

Supports projects to develop or enhance programs and processes to meet regulatory reporting requirements.

Minimum of Bachelor’s degree with a preference to science, health care or engineering degree and 0-2 years of relevant experience.

Education Required: Bachelors Degree, with a preference to science, health care or engineering degree

Years’ Experience Required: 0-2 yrs

Review of legal documents, including post market surveillance documentation related to on-going litigation.

Supports intake evaluation, processing, and communications and investigations on complaints and adverse events according to procedures and government regulations.

Hands-on experience with EU MDR or large remediation projects PMP certification

Scope of Engagement: EU MDR Program Management Support

Identification and timely escalation of project risks to management

Take on project management remediation process which includes coordinating with program workstream leaders to manage 1 Class II/III Submissions

Responsibilities will include but are not limited to the following:

5+ years managing compliance, remediation, or new product development projects within the medical device industry preferred.

Manages schedules, reviews status of projects, and prepares status reports on an ongoing basis

4 years of administrative/project support experience

Responsibilities may include the following and other duties may be assigned:

Ensures timely and quality completion of regulatory data forms verifying data as well as identifying, managing, and resolving data discrepancies

Tracks project timeline and global regulatory submission data

Maintains file-specific correspondence and other required documentation

Manages schedules, reviews status of projects, and prepares status reports on an ongoing basis

4 years of administrative/project support experience

MDR- Project Coordinator III (Regulatory) (Through end of April 2024 // REMOTE, team based in MA):

Education: Associate’s or Bachelor’s degree preferred

Ensures timely and quality completion of regulatory data forms verifying data as well as identifying, managing, and resolving data discrepancies

Tracks project timeline and global regulatory submission data