The Regulatory Compliance Manager is both the primary global compliance manager and the primary corporate site compliance manager. He/she is responsible for strategic and tactical planning, for ensuring that all products being developed and being produced is compliant with internal product specifications, meets all customer requirements, and is compliant with all regulatory and 3 rd party certifications, regulations, and policies.
Note: Some travel may be required in this position. Estimated no more than 10 to 20%.
Stay abreast with changes to regulatory, environmental and customer requirements along with recommending actions required to maintain compliance and communicate any changes to the global organization.
Ensure implementation and compliance of all and regulatory policies and practices.
Make sure all manufactured products maintain regulatory certifications. (CE, MDR, FDA, ISO, etc.)
Act as point of contact and subject matter expert for R&D regulations and compliance internally and externally. Collect knowledge on various product regulations for use in customer interactions and internal knowledge sharing.
Other projects and tasks as assigned by Quality Management tea m and/or as dictated by needs of the business and approved by Site Quality Leader.
Prevent compliance issues by collaborating with the engineering and the product development teams
Collaborate with other global sites and QMS or compliance personnel
Develop and maintain the QMS system to comply with ISO 9001, ISO 1 3485, FDA 21 CFR Part 11, and other standards on a site -by-site, region-by-region basis.
Training the workforce on daily compliance to processes and procedures and the importance of following the standards
Perform compliance reviews, as part of NPI, including safety, regulatory, environmental compliance (RoHS, REACH, Conflict Minerals) and risk assessment of potential sources of supply.
Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.
Review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer to manufacturing and suppliers.
Machinery operation requires the use of safety equipment to include but not limited to; eye safety glasses, hearing protectors, work boots and hardhats. Loose fitting clothes and jewelry are not permitted.
NOTE: This job description in no way states or implies that these are the only duties to be performed. Employee will be required to follow any other instructions and to perform any other duties requested by employees’ supervisor and/or manager.
We at Spellman High Voltage Electronics Corporation believe that each individual is entitled to equal employment opportunities without regard to race, color, creed, gender, sexual orientation, gender identity, marital status, national origin, age, veteran status or disability. The right of equal employment opportunity extends to recruiting, hiring selection, transfer, promotion, training and all other conditions of employment.
Note to Recruiters and Placement Agencies: Spellman High Voltage Electronics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any Spellman High Voltage Electronics employee. Spellman High Voltage Electronics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Spellman High Voltage Electronics and will be processed accordingly.
BS/ MS in Electrical Engineering or relevant experience
FDA regulatory experience / ISO13485 experience a plus / European Medical Device Regulation MDR experience preferred
6 to 8 years previous experience working in regulatory compliance roles within electronics manufacturing, R&D, or related industry.
Previous experience working directly with certification and regulatory agencies is preferred
Self-starter mentality with the ability to confidently work independently.
Previous working experience with compliance in both domestic and international markets is preferred.
Outstanding project management skills
Ability to work in a fast paced and demanding atmosphere
Excellent communication skills both written and verbal
Attention to Detail
Ability to work independently and exercise sound judgment and discretion
Project Management Skills
Previous Global Experience
Strong organizational and time management skills
Proficient in Word, Excel, Project, Power Point, Minitab, as well as hardware and software tools to accomplish day to day work activities
About Spellman High Voltage Electronics Corporation
Who We Are
Spellman, a family owned and managed company established in 1947, is the world's leading independent supplier of precision DC high voltage power supplies, X-Ray generators and Monoblock® X-Ray sources for medical, industrial and scientific applications. While we offer the broadest and most advanced range of standard and platform products in the industry, we specialize in partnering with OEM’s to develop, produce and support the optimum solution for each system and market segment. We currently have five design centers, six production centers, eight repair locations and over 2,100 employees in North America, Europe and Asia.