Post Market Associate
NOVA Biomedical GmbH, Billerica, MA, United States
Nova Biomedical offers a career as a Post Market Associate. The role provides support to the QA function by performing activities associated with customer product complaints, including receipt, evaluation, investigation, trending, reporting, and closure. The Associate also supports Post‑Market Surveillance (PMS).
What you’ll do
Primary ownership for complaints and post‑market surveillance utilizing the Complaint Handling platform.
Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System per Advanced Instruments procedures, GMP’s, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements.
Make reportability decisions and submit MDR reports.
Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause.
Update complaint records to reflect investigation findings, perform risk assessments, make corrective action assessments based on investigation findings, and close complaints.
Provide support to cross‑functional teams related to complaint management.
Works with Field Personnel to resolve customer complaints in a timely manner.
Work cross‑functionally to support CAPA investigations, root‑cause determinations and risk evaluations as required.
Trend complaint root causes to identify potential improvement opportunities.
In coordination with Regulatory Affairs (RA) document and implement PMS Plans for all product families.
Execute PMS plans in the commercial lifecycle by collecting information and data and completing PMS reports as required.
Provide assistance in controlled document management and quality records management.
Participate in internal and external audits.
Promote a culture of quality focused on compliance with customer needs and regulatory requirements.
Other duties as assigned.
What we are looking for in you
Knowledge of ISO 13485, MDSAP and FDA QSR required; other regulatory jurisdictions strongly preferred.
Must be able to use Microsoft Office, Adobe, as well as be comfortable in eQMS and ERP company software.
Experience with Salesforce.
Experience with in vitro diagnostics (IVD / IVDR) preferred; other applicable experience is a plus.
Power BI experience.
3+ years related experience and/or training; or equivalent combination of education and experience preferred.
Bachelor’s Degree in a scientific/technical discipline.
Quality / Regulatory certifications a plus.
Physical Requirements
Minimum 4 days onsite requirement to support the business.
Must be able to use basic office equipment: Computer, Printer, Copier, Telephone, etc.
Must be capable of communicating with stakeholders.
Benefits
Competitive 401(k) company match.
Bonus Program, Generous PTO and paid holidays.
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.
Targeted Salary Range: $55,000 - $63,000/year.
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 candidate’s experience and may vary based on individual factors such as location, skills, and education.
EEO Statement:
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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What you’ll do
Primary ownership for complaints and post‑market surveillance utilizing the Complaint Handling platform.
Initiate complaint files and document complaint and regulatory reportability assessment within the Complaint Handling System per Advanced Instruments procedures, GMP’s, 21 CFR 803, 820, ISO 13485, and other applicable national regulatory requirements.
Make reportability decisions and submit MDR reports.
Conduct preliminary complaint investigations including DHR review, shipment and lot history review, and trending to aid in determination of root cause.
Update complaint records to reflect investigation findings, perform risk assessments, make corrective action assessments based on investigation findings, and close complaints.
Provide support to cross‑functional teams related to complaint management.
Works with Field Personnel to resolve customer complaints in a timely manner.
Work cross‑functionally to support CAPA investigations, root‑cause determinations and risk evaluations as required.
Trend complaint root causes to identify potential improvement opportunities.
In coordination with Regulatory Affairs (RA) document and implement PMS Plans for all product families.
Execute PMS plans in the commercial lifecycle by collecting information and data and completing PMS reports as required.
Provide assistance in controlled document management and quality records management.
Participate in internal and external audits.
Promote a culture of quality focused on compliance with customer needs and regulatory requirements.
Other duties as assigned.
What we are looking for in you
Knowledge of ISO 13485, MDSAP and FDA QSR required; other regulatory jurisdictions strongly preferred.
Must be able to use Microsoft Office, Adobe, as well as be comfortable in eQMS and ERP company software.
Experience with Salesforce.
Experience with in vitro diagnostics (IVD / IVDR) preferred; other applicable experience is a plus.
Power BI experience.
3+ years related experience and/or training; or equivalent combination of education and experience preferred.
Bachelor’s Degree in a scientific/technical discipline.
Quality / Regulatory certifications a plus.
Physical Requirements
Minimum 4 days onsite requirement to support the business.
Must be able to use basic office equipment: Computer, Printer, Copier, Telephone, etc.
Must be capable of communicating with stakeholders.
Benefits
Competitive 401(k) company match.
Bonus Program, Generous PTO and paid holidays.
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.
Targeted Salary Range: $55,000 - $63,000/year.
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 candidate’s experience and may vary based on individual factors such as location, skills, and education.
EEO Statement:
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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