PLYMOUTH, MA 02360
Responsibilities of the Compliance Manager:
Ensuring the company adheres to legal standards and in-house policies.
Conduct activities to ensure execution of compliance standards.
Identify vulnerabilities, report findings and make recommended solutions for corrective action.
Complete various reports and file with regulatory agencies.
Research, monitor and execute compliance tasks of corporate-wide scope, complexity and risk.
Identify potential areas of compliance vulnerability and risk
Report findings and provide general guidance on prevention and avoidance
Develop and implement corrective action plans for resolution.
Create corrective action plans, communicate and manage the change to ensure compliance with federal, state, agency, legal, regulatory as well as internal requirements.
Monitor federal import and export requirements ensuring compliance; provide instructions for those affected establishing systems for compliance.
Work on special projects and audits as assigned.
Minimum 5 to 7 years of compliance, regulatory or quality experience in a medical device organization.
Education and/or experience equivalent to a Bachelor's Degree in Business, or related field
Strong knowledge of the ISO 13485 and 21 CFR 820 QMS
Understanding of FDA regulation and pertinent state and federal laws governing medical products manufacturing and marketing.
Excellent verbal and written communication skills
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Familiarity with operational, quality assurance, and human resources procedures and regulations.
Regulatory experience in Medical Device and FDA environment is a plus
Knowledge of Code of Federal Regulations, and Federal Acquisition Regulations for Government contracts a plus.
Salary for the Compliance Manger is $85, 000-95, 000 based on qualifications
Benefits: We recognize people as our most valuable asset. We have one of the most competitive benefit packages in the industry. Health Insurance, Dental Insurance, Paid Vacation and Sick Time.
It is the policy of The Alpha Group, Inc. To recruit, hire, train, compensate, promote, and provide other conditions of employment without regard to a person s race, color, religion, national origin, sex, age, disability, veteran status or other characteristic protected by law.