4 Robbins Road Westford, MA 01886 US
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.
• 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.
• 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.
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.