Product Surveillance Clinical MDR Specialist I (Remote)

REMOTEPosted 20 days ago

Job summary

• Job post source

  This job is directly from Arthrex

• Job overview

  The Product Surveillance Clinical MDR Specialist I at Arthrex is responsible for evaluating and investigating adverse event complaints related to medical devices, ensuring regulatory compliance and patient safety.

• Responsibilities and impact

  The role involves evaluating complaints, submitting adverse event reports to regulatory agencies, meeting deadlines, examining medical records, corresponding with stakeholders, closing complaint files, preparing closing letters, monitoring FDA databases, and participating in audits.

• Compensation and benefits

  The salary range is $68,500 to $94,750 with benefits including medical, dental, vision insurance, life insurance, flexible spending accounts, supplemental insurance, 401(k) matching, annual bonus, wellness programs, gym and tuition reimbursement, paid parental leave, PTO, volunteer PTO, and employee assistance programs.

• Experience and skills

  A bachelor's degree in Health Sciences, Biomedical Engineering, Nursing, Risk Management or related field is required; experience in medical device or pharma industry with adverse event reporting is preferred; knowledge of FDA, ISO, EU MDR regulations and proficiency in PC software including Excel and Word are necessary.

• Career development

  Opportunities include working in a global medical device company with exposure to regulatory compliance and medical device surveillance, supporting professional growth in regulatory affairs and quality assurance.

• Work environment and culture

  Arthrex promotes a supportive and inclusive work environment with a focus on innovation, employee wellness, and diversity, offering remote work options for this position.

• Company information

  Arthrex is a global leader in medical device development and medical education in orthopedics, known for innovative products and commitment to helping surgeons treat patients better.

• Job location and travel

  This position is remote, allowing work from any location.

• Unique job features

  The role offers unique exposure to global regulatory environments, involvement in FDA and ISO audits, and the chance to impact patient safety through medical device complaint surveillance.

Company overview

Arthrex is a global medical device company that specializes in orthopedic products and minimally invasive surgical technology. Founded in 1981 by Reinhold Schmieding, the company has grown to become a leader in the field, providing innovative solutions for sports medicine, trauma, and orthopedic surgery. Arthrex generates revenue through the design, manufacturing, and distribution of its extensive range of medical devices and surgical instruments. With a strong commitment to medical education, Arthrex also offers comprehensive training programs for healthcare professionals to ensure the effective use of their products.

How to land this job

• Tailor your resume to highlight your knowledge and experience with FDA 21 CFR 820, cGMP, ISO13485:2016, EU MDR, and MDSAP regulations, emphasizing your ability to handle adverse event reporting in the medical device industry.

• Emphasize your skills in evaluating complaints, investigating adverse events, and preparing regulatory submissions to U.S. and international agencies, showcasing your attention to detail and regulatory compliance expertise.

• Apply through multiple channels such as Arthrex's corporate careers site, LinkedIn, and other job boards where the position is listed to maximize your chances of being noticed.

• Connect with professionals in Arthrex's regulatory affairs or product surveillance teams on LinkedIn; start conversations by mentioning your interest in their work on medical device safety or asking about their experience with FDA audits and reporting processes.

• Optimize your resume for ATS by incorporating keywords from the job description like 'adverse event reporting,' 'FDA 21 CFR 820,' 'ISO13485,' 'regulatory submissions,' and 'medical device compliance' to ensure your application passes initial screenings.

• Use Jennie Johnson's Power Apply feature to automate applying through multiple platforms, tailor your resume for ATS, and identify relevant Arthrex contacts on LinkedIn so you can focus your energy on preparing for interviews and networking effectively.