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Our client is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, join their growing team!
Are you ready to make a difference in the Post Market Surveillance and Regulatory reporting program? We are seeking a dedicated individual to ensure compliance with FDA's Quality System Regulation (QSR), Good Manufacturing Practices (GMP), MDD, EU MDR, MDSAP, and ISO 13485 standards. As a Regulatory Compliance Specialist, you will play a vital role in meeting Post Market Surveillance obligations related to ZOLL devices.
Key Responsibilities:
Maintain Post Market Surveillance documentation to meet Regulatory requirements and stand strong during audits.
Prepare and submit documentation for reportable events to Competent Authorities within specified timelines.
Coordinate the closure of complaint records in our Post Market Surveillance system.
Manage the storage and retrieval of active and inactive complaint records.
Provide support for Post Market Surveillance activities and assist in the review of customer communications for complaint reporting.
Communicate effectively with customers and internal departments.
Qualifications:
High School diploma required.
1-3+ years of experience in the Healthcare or Medical Device Industry preferred.
Regulatory certification exposure to Post Market Surveillance is a plus.
Knowledge of FDA QSR, MDD, MDR, ISO 13485, and MDSAP preferred.
Strong verbal and written communication skills.
Ability to work collaboratively and independently with minimal supervision.
Attention to detail and commitment to quality work.
Effective time management skills.
Positive attitude and forward-thinking mindset.
Analytical skills and ability to take initiative to solve problems.
Previous experience in Quality or Regulatory roles in the Medical Device industry preferred.
Think you know someone who'd be perfect for this role?
Even if you're not interested in this job opportunity, if you refer someone who gets hired for this position (or any other opening!), we'll show our appreciation with a referral bonus.
Spread the word and help us find top talent!
Stay in the Loop:
Techneeds has offered contract-to-hire and direct-hire talent solutions to some of the best employers in New England for over 45 years. As a Technology, Manufacturing, and Engineering staffing & recruitment agency, we’re experts at finding, screening, and placing in-demand talent with top employers in New England.
Post Market Surveillance Coordinator
2024-08-28
2024-10-19
Employment Type:
Contract
Industry: Light Industrial/Manufacturing, Professional/Administrative
Job Number: 61269
Office Location: Salem
Job Description
Our client is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, join their growing team!
Are you ready to make a difference in the Post Market Surveillance and Regulatory reporting program? We are seeking a dedicated individual to ensure compliance with FDA's Quality System Regulation (QSR), Good Manufacturing Practices (GMP), MDD, EU MDR, MDSAP, and ISO 13485 standards. As a Regulatory Compliance Specialist, you will play a vital role in meeting Post Market Surveillance obligations related to ZOLL devices.
Key Responsibilities:
Maintain Post Market Surveillance documentation to meet Regulatory requirements and stand strong during audits.
Prepare and submit documentation for reportable events to Competent Authorities within specified timelines.
Coordinate the closure of complaint records in our Post Market Surveillance system.
Manage the storage and retrieval of active and inactive complaint records.
Provide support for Post Market Surveillance activities and assist in the review of customer communications for complaint reporting.
Communicate effectively with customers and internal departments.
Qualifications:
High School diploma required.
1-3+ years of experience in the Healthcare or Medical Device Industry preferred.
Regulatory certification exposure to Post Market Surveillance is a plus.
Knowledge of FDA QSR, MDD, MDR, ISO 13485, and MDSAP preferred.
Strong verbal and written communication skills.
Ability to work collaboratively and independently with minimal supervision.
Attention to detail and commitment to quality work.
Effective time management skills.
Positive attitude and forward-thinking mindset.
Analytical skills and ability to take initiative to solve problems.
Previous experience in Quality or Regulatory roles in the Medical Device industry preferred.
Think you know someone who'd be perfect for this role?
Even if you're not interested in this job opportunity, if you refer someone who gets hired for this position (or any other opening!), we'll show our appreciation with a referral bonus.
Spread the word and help us find top talent!
Stay in the Loop:
- Sign up for email notifications to hear about new openings as they're posted.
- Visit http://jobs.techneeds.com regularly to see our latest opportunities.
Techneeds has offered contract-to-hire and direct-hire talent solutions to some of the best employers in New England for over 45 years. As a Technology, Manufacturing, and Engineering staffing & recruitment agency, we’re experts at finding, screening, and placing in-demand talent with top employers in New England.
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