The Role
Supports post-market quality activities for medical devices by reviewing complaints, assessing MDR reportability and patient safety impact, preparing regulatory reports, supporting investigations, maintaining eQMS records, and contributing to surveillance, trending, and compliance initiatives. Collaborates with Quality, Regulatory, Engineering, Manufacturing, and Clinical teams while ensuring adherence to FDA regulations, ISO standards, and internal quality systems.
Summary Generated by Built In
This is a remote position.
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are seeking an experienced MDR Specialist to support post-market quality activities for medical devices. This individual will be responsible for evaluating complaints, assessing regulatory reporting requirements, supporting adverse event investigations, and ensuring compliance with applicable quality system and regulatory standards. The ideal candidate has experience in complaint handling, Medical Device Reporting (MDR), and post-market surveillance within a regulated medical device environment.
This is a full-time, 3 month contract remote role, with the potential to extend after the initial contract end date.
- Review and assess product complaints in accordance with company procedures and regulatory requirements.
- Evaluate complaint events for reportability and potential patient safety impact on designated medical device system.
- Prepare and submit Medical Device Reports (MDRs) and related regulatory documentation.
- Conduct or support complaint investigations and ensure timely documentation and closure of records.
- Collaborate with cross-functional teams, including Quality, Regulatory Affairs, Engineering, Manufacturing, and Clinical personnel, to gather and evaluate information.
- Support post-market surveillance activities and trending efforts.
- Maintain accurate and compliant records within electronic quality management systems (eQMS).
- Contribute to continuous improvement initiatives related to complaint handling and regulatory compliance.
- Ensure activities are performed in accordance with FDA regulations, ISO standards, and internal quality system requirements.
Requirements
- Bachelor's degree in a scientific, engineering, healthcare, or related discipline, or equivalent experience.
- 5+ years of experience in medical device complaint handling, vigilance, post-market surveillance, or quality assurance.
- Experience authoring and submitting Medical Device Reports (MDRs) and assessing regulatory reportability.
- Knowledge of FDA medical device regulations, including 21 CFR Part 803 and 21 CFR Part 820, as well as ISO 13485.
- Experience conducting complaint investigations and supporting risk-based decision making.
- Familiarity with electronic quality management systems (eQMS) and complaint management tools.
- Strong technical writing, communication, and analytical skills.
- Ability to work independently in a fast-paced, highly regulated environment.
Preferred Qualifications
- Experience supporting Class II or Class III medical devices.
- Previous experience in post-market surveillance, complaint trending, or device vigilance programs.
- Working knowledge of risk management principles and adverse event reporting processes.
Benefits
W2 temp roles include our Medical and Sick Time benefits.
The hourly bracket for this role is set between $35 - $38.25 hourly. The rate offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- Bachelor's degree in a scientific, engineering, healthcare, or related discipline, or equivalent experience
- 5+ years of experience in medical device complaint handling, vigilance, post-market surveillance, or quality assurance
- Experience authoring and submitting Medical Device Reports and assessing regulatory reportability
- Knowledge of FDA medical device regulations, including 21 CFR Part 803 and 21 CFR Part 820, and ISO 13485
- Experience conducting complaint investigations and supporting risk-based decision making
- Familiarity with electronic quality management systems and complaint management tools
- Strong technical writing, communication, and analytical skills
- Ability to work independently in a fast-paced, highly regulated environment
- Experience supporting Class II or Class III medical devices
- Experience in post-market surveillance, complaint trending, or device vigilance programs
- Working knowledge of risk management principles and adverse event reporting processes
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
