MDR Data Specialist

Opportunity to work for one of the world's largest suppliers of eye products! Primary responsibility is to support the global device complaint management quality system operations in regard to global reporting obligations for all medical device complaint related activities.

Job Description:

• Support PMS related Projects to improve source data required for PMS activities. Support department projects and / or participate in cross functional projects as required.

• Perform periodic maintenance and review of PMS Systems.

• Collaborate with key contributors to collect the necessary information to fulfill the requirements of the post market surveillance review.

• Work closely with Product Quality Managers, Medical Safety, Quality Analytics and Customer Relations Staff to develop, review, edit and facilitate timely completion of PMS reports and other outputs of Safety Management Team.

• Perform periodic trend analysis as an early warning system on complaint data. Generate or apply statistical methods with appropriate risk-based justification.

• Generate periodic reports as requester per government agencies and/or Notified Bodies

• Perform other related duties as assigned by management.

Must Haves:

• Good analytical skills

• Reviewing trends

• Example of analytic programs and understand how to devise

• SAS & R: Statistical programming for clinical trial data analysis

• Biomedical Engineering grads would be good for this role with 1+ year of industry experience

• Bachelor's Degree in a Science Discipline (Engineering preferred)

• Systems: SQL/Python/ knowledge in AWS

Skills:

• iso 9001, product complaints, quality, medical device, post market surveillance, capa

Additional Skills & Qualifications:

• 4 Years bachelor's level degree in engineering

• Demonstrated analytical capabilities with the ability to summarize data into graphs, charts and statistics using software is required.

• Experience executing data management tasks is preferred. Ability to use Excel basic understanding of a statistical software language, and proficiency in a programming language is preferred.

• Experience with technical writing for documents are required. Ability to communicate in a professional manner, including generating and presenting well-written reports and presentations is required.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.