Compliance Manager
Alpharetta, GA, United States
Hilco Vision is an industry leading global eyewear/eye care company delivering comprehensive solutions to customers, built on a platform of innovation and operational excellence. It has direct subsidiaries in the USA, Canada, UK, Germany, Australia, China, Hong Kong, Belgium and the Netherlands. The company's product portfolio encompasses Prescription Safety, Lenscare, Eyewear Accessories, Lab & Dispensing, Ocular Surface, Exam Supplies, and Vision Testing.
Bruder Healthcare is looking for a Compliance Manager to join the team! As the Compliance Manager at Bruder Healthcare, a division of Hilco Vision, you will be a valued resource responsible for company compliance. This visible role with a growing and dynamic company, requires the ability to work globally, cross-functionally and independently, think creatively, and be responsive to the needs of the business. You will partner with business stakeholders and external consultants to implement and align Company policies and procedures to ensure regulatory requirements and compliance needs are met.
If you are up for the challenge and want to be a key part of a winning team, we'd love to hear from you!
Qualifications:
Bachelor's degree and 4-6 years of regulatory experience relating to U.S. and international regulatory compliance (Europe required and China preferred).
Thorough understanding of FDA and select international medical device regulations.
Experience in drafting domestic and international registrations and submissions such as FDA, ETL and CE. Knowledge of UDI, UKCA, MDR and CE requirements and registrations is critical. Familiarity with 21 CFR Part 820 and Mdel is desirable.
Knowledge of existing and proposed laws and regulations that could impact business practices.
Familiar with researching legislation and regulatory guidance and are capable of developing and controlling corporate compliance policies and procedures in a matrix organization.
Thorough understanding of regulations applicable to the conduct of clinical trials.
General understanding of product development process and design control.
Excellent interpersonal and communications skills.
Responsibilities: Research and summarize regulations from statutory and non-statutory sources in all global markets where Bruder conducts business and emerging markets into which Bruder plans to expand.
Use regulatory knowledge, to work with team members to navigate regulation in their day-to-day functions such as providing support and direction on Export Controls and compliance with international export regulations.
Implement and maintain company compliance policies and procedureswork with team members to ensure they understand their roles and responsibilities defined in the specific compliance-related Bruder policies and procedures.
Subject matter expert on product compliance; software validation and packaging requirements by product.
Conduct audits on company compliance with policies and procedures; Coordinate with customers, vendors and regulatory bodies on certification questionnaires; and quality, information security and regulatory audits.
Review company service call records to maintain and enhance company CAPA procedures.
Coordinate with supporting consultants and organizations to drive compliance activities.
Support Product Development by assessing compliance needs for new products and components.
Other duties as assigned.