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Quality Analyst

Westford, MA 01886

Posted: 03/23/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 548041 Is job remote?: No Country: United States

Job Description

Job Summary:
We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team. The successful candidate will be responsible for ensuring that our organization complies with all relevant medical device regulations, EUMDR laws, and ISO standards. The Regulatory Compliance Specialist will monitor and assess our organization's adherence to these rules and develop and implement strategies to improve our compliance.

Responsibilities:
•    Stay up-to-date with relevant regulatory requirements, laws, and standards.
•    Develop and implement compliance policies and procedures.
•    Monitor and assess the organization's compliance with relevant GMP and GDP programs. 
•    Participate in regular internal and external compliance audits and assessments.
•    Provide training to employees on compliance matters and inspection readiness.
•    Investigate compliance violations and recommend corrective actions.
•    Facilitate management reviews and business meetings with senior leadership at the company and maintain records of the meeting minutes and outcomes.
•    Collaborate with other departments and teams to improve compliance across the facility.

Requirements:
•    Bachelor's degree in a relevant field such as medical device, bioinformatics, biomed engineering, business administration, or a related discipline.
•    At least 2-3 years of experience in a regulatory compliance role, preferably in a medical device or related industry.
•    Excellent attention to detail and typing skills to capture the action items during business reviews.
•    Strong communication and interpersonal skills.
•    Ability to work independently and as part of a team.
•    Hands on experience using MS Office (Excel) for data analysis and reporting is a plus.
 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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