Principal Compliance Program Manager

CORE RESPONSIBILITIES

• Implement a Product Environment Compliance strategy, process and deploy applicable standard operating procedures for new product development and design changes to existing products.
• Manage PROCEPT compliance to EU requirements of CE, IEC, supply chain act and FDA regulations of medical devices with respect to the Environmental Regulations of WEEE and Battery, REACH, Conflict minerals, China RoHS and EU RoHS.
• Assist Engineering and Supplier related activities and processes of PROCEPT BioRobotics business units to close gaps and incorporate compliance into new product design while maintaining compliance for existing products.
• Track the results to identify product compliance and communicate to senior management and internal stakeholders.
• Work cross-functionally with Engineering, sustaining Engineering, Purchasing, supply chain, Customer Service and relevant internal departments/functions in the Business Units to provide technical expertise and support, and to catalyze actions needed to meet program goals.
• Support Risk Management activities including improving the risk management process and maintenance of the Risk management procedure.
• Provide Senior Management with agreed upon compliance program goals, objectives and metrics.
• Point of contact to create, review and approve responses/statements to customer/distributor/customs environmental inquiries.
• Assist QA department in quality audits including FDA and Notified Body and respond to non-conformities, as necessary.
• Support corrective and preventive action process for design and quality assurance process related CAPA.
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance.
• Understand and adhere to the PROCEPT BioRobotics Quality and EHS policies.

QUALIFICATIONS (Education, Experience, Certifications)

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelor’s degree in chemical, Material Sciences or Biomedical Engineering.
• Minimum of 12 years of product environmental compliance management experience and engineering related activities for the design development and manufacturing of electromechanical products.
• Strong data management analysis capabilities required.
• Understanding of process chemistries, materials and substances present in manufactured parts.
• Familiarity with ECHA guidelines, EU MDR requirements on CMR and Endocrine disruptors
• Must be detail oriented, well organized and have excellent communication skills.
• Must work well with team.
• Ability to manage multiple projects at the same time.
• Ability to write reports, customer facing correspondence, and procedure manuals.
• Must be detail-oriented with strong written and oral communication skills.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Flexibility and adaptability to accept new tasks.
• Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The employee is occasionally required to attend animal or cadaver labs and to manipulate models and/or organs for testing
• The employee occasionally packs and unpacks packages.
• The employee will occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. The environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
• The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment will be assigned and worn.
• The employee will occasionally be exposed to clinical operating rooms, for which proper personal protection equipment will be assigned and worn.
• While performing the duties of this job, the employee is regularly working in a warehouse environment.