Post Market Associate
Nova Biomedical Corporation
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Benefits offered by this job
Job summary
Nova Biomedical Corporation in Waltham, MA is seeking a Post Market Associate to support Quality Assurance through handling customer product complaints, post market surveillance, and regulatory compliance across the product lifecycle.
You'll own complaint and PMS activities, document evaluations, prepare MDRs, and collaborate with cross-functional teams to drive CAPAs and product improvements. A science/technical background and experience with ISO/FDA regulatory requirements are preferred.
Qualifications
- Knowledge of ISO 13485, MDSAP, and FDA Quality System Regulations required.
- Experience with global regulatory requirements preferred.
- Proficiency with Microsoft Office and Adobe applications.
- Experience working with eQMS and ERP systems.
- Experience with Salesforce, Power BI.
- Experience with in vitro diagnostics (IVD/IVDR) preferred.
- Strong written communication skills.
- Strong attention to detail.
- Minimum of 3 years of related experience and/or training preferred.
- Bachelor's degree in a scientific or technical discipline.
- Quality and/or Regulatory certifications are a plus.
Responsibilities
- Own complaint and post market surveillance activities using the Complaint Handling platform.
- Initiate complaint files and document evaluations and regulatory reportability assessments.
- Make reportability determinations and submit MDRs as required.
- Conduct preliminary investigations including Device History Record reviews and trend analyses.
- Update complaint records with investigation findings and perform risk assessments.
- Provide cross-functional support for complaint management activities.
- Collaborate with Field Personnel to resolve customer complaints promptly.
- Support CAPA investigations and root cause determinations.
- Trend root causes to identify product and process improvements.
- Document and implement Post Market Surveillance plans across product families.
Skills
Education
Tools
Job description
The Post Market Associate provides support to the Quality Assurance function by performing activities associated with customer product complaints including receipt evaluation investigation trending reporting and closure. This role also supports Post Market Surveillance PMS activities and works closely with cross functional teams to ensure compliance with quality system and regulatory requirements throughout the product lifecycle.
- Own complaint and post market surveillance activities utilizing the Complaint Handling platform
- Initiate complaint files and document complaint evaluations and regulatory reportability assessments within the Complaint Handling System in accordance with company procedures GMPs FDA regulations ISO standards and other applicable regulatory requirements
- Make reportability determinations and submit Medical Device Reports MDRs as required
- Conduct preliminary complaint investigations including Device History Record reviews shipment and lot history reviews and complaint trending to support root cause analysis
- Update complaint records to reflect investigation findings perform risk assessments assess corrective actions and close complaint records
- Provide support to cross functional teams related to complaint management activities
- Work with Field Personnel to resolve customer complaints in a timely manner
- Support CAPA investigations root cause determinations and risk evaluations
- Trend complaint root causes to identify opportunities for product and process improvement
- Partner with Regulatory Affairs to document and implement Post Market Surveillance plans for all product families
- Execute PMS plans throughout the commercial lifecycle by collecting data analyzing information and completing PMS reports
- Support controlled document management and quality records management activities
- Participate in internal and external audits
- Promote a culture of quality and compliance focused on customer needs and regulatory requirements
- Perform other duties as assigned
- Knowledge of ISO 13485 MDSAP and FDA Quality System Regulations required
- Experience with additional global regulatory requirements preferred
- Proficiency with Microsoft Office and Adobe applications
- Experience working with eQMS and ERP systems
- Experience with Salesforce
- Experience with Power BI
- Experience with in vitro diagnostics IVDIVDR preferred
- Strong written communication skills
- Strong attention to detail
- Minimum of 3 years of related experience andor training preferred
- Bachelors degree in a scientific or technical discipline
- Quality andor Regulatory certifications are a plus
- Comfort with working at a computer for extended periods
- Capacity to lift and carry up to 2550 pounds as required
- Able to communicate effectively via phone video and written communication
- Occasional need to move about the office to access meetings or resources
- Flexible Medical Dental & Vision Coverage
- Competitive 401k company match
- Bonus Program
- Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development engagement and events
- Company marketplace for lunch and snacks in our Norwood MA Billerica MA and Westbrook ME offices
- Company subsidized cafeteria in our Waltham MA office
Waltham
3787 4748hr
Nova Biomedical believes in transparency and integrity throughout all we do including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidates experience and may vary based on individual factors such as location skills and education.
At Nova Biomedical were not just building instruments were powering breakthroughs that improve lives. Our smart science driven solutions are trusted in over 100 countries to speed drug development and enhance patient care. Our integration brings together more than 70 years of scientific excellence with Novas cutting edge innovation forming a powerhouse of precision purpose and possibility. With FDA registered ISO certified manufacturing more than 125 FDA approvals and industry trusted diagnostics were setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic IVD instrumentation dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. With headquarters in Norwood and Waltham Massachusetts and a global team of nearly 2000 employees were building a collaborative empowered culture grounded in shared values Customer Centricity Ingenuity Ownership & Accountability Collaboration and Integrity. Working at Nova Biomedical means joining a mission driven organization where your contributions matter. Whether youre in engineering science manufacturing or support youll be part of a team that values innovation invests in your growth and is committed to making a real world impact on global health. Explore whats next with us at novabiomedicalcom
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce.
As a part of our commitment to a diverse and inclusive workforce Nova Biomedical will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identity gender expression veteran status age mental or physical disability genetic information or any other protected class.
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