Regulatory Specialist - SP Scientific
Location: Warminster, PA
FLSA Status: Salaried Exempt
SP Industries is seeking a passionate, driven, and creative Regulatory Specialist to take the SP Scientific Division to the next level. The ideal candidate will have a strong background in Regulatory / Compliance process development and quality systems, will be a team builder, and will thrive on building relationships both internally and externally.
This leader must thrive on challenging the status quo, and have a passion for designing, leading, and implementing cross-functional/ process improvements.
This leader should be able to positively manage a skilled workforce by focusing on talent development and succession planning. Most importantly, this candidate must create a culture that embraces change and focuses on continuous operational and process improvements that further enhance the customer experience with SP's products and services.
This position will spend time working in both the shop and office areas. We expect this to be a hands-on position where he / she will be working on the shop floor a good deal of time due to the supervision of processes pertaining to compliance on design, fabrication and assembly.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Provide regulatory affairs support to design teams and the document control/change request system
- Refreshes training for current company associates and trains new associates.
- Prepare Technical File, CE Mark, and other related regulatory filings
- Assist with preparation of U.S. regulatory submissions, Design Dossiers for European Union submissions, technical files, reviewing design control documents, and being an active member of design teams representing the regulatory affairs responsibility
- Develop, document, and implement regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements
- Maintain and updates guidelines relating to international and domestic regulations for finished products and raw materials: ROHS / REACH / CM / F-Gas / ASME / PED etc.
- Provides regulatory documents in compliance with customer and country-specific requirements.
- Works in partnership with manufacturing and QA/QC in enhancing quality management systems to facilitate overall regulatory compliance.
- Drafts, maintains, and updates regulatory guidelines, positions, SOPs for the department.
- Perform daily quality audits of product & process to ensure products are manufactured to established specification
- Interprets and implements quality assurance standards
- Collect and compile information to provide reporting on all inspection results, vendor scorecard data and communicate to organization members
- Establish and maintain regulatory standards, procedures and controls.
- Perform internal audits or products and procedures and take corrective action as needed.
- Manage and maintain compliance with regulatory bodies.
- Identify and implement best practices to optimize product quality and improve efficiency.
- Supervise inbound-inspection personnel for vendor and customer provided products.
- Other duties as assigned.To perform this job successfully, an individual should possess the minimum qualifications cited.
- Education, Experience, and Work Skills
Qualifications: Education, Experience, Skills, and Certifications
- B.S. or equivalent work experience, or combination of education and experience required.
- 5 years or more quality or related work experience required.
- Previous experience in regulatory, compliance, quality processes required.
- Strong analytics and structured problem solving experience.
- Thorough understanding of ISO standards and conformance.
- Strong project management skills.
- Ability to interact effectively with internal and external customers.
- Excellent people skills with the ability to evaluate, coach, and motivate employees.
- Proficient in the use of MS Office, Outlook, Word, Excel and PowerPoint applications.
- Knowledge of Agile methodologies.
- Excellent verbal and written communication skills
- Able to understand and review technical documentation, including project plans, test procedures, and design documents
Certificates, Licenses, Registrations
- ASQ Certification preferred (CQM, CQE, CQA)
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 regularly required to talk and listen.
- The employee is regularly required to use color vision and adjust focus between near and far objects.
- The employee is regularly required to stand, walk, climb, crawl, bend and sit.
- The employee is regularly required to use normal office tools, equipment and PC's.
- The employee is regularly required to handle shop tools and equipment controls.
- The employee is regularly required to use of arms and hands to climb and balance.
- The employee is regularly required to use the following senses: sight (close, distance, color, peripheral and depth perception), hearing talking, taste and smell.
- The employee may be required to lift up to 70 pounds, occasionally moving larger objects with assistance.
- The employee is occasionally required to work in tight spaces with difficult access.
- The employee is occasionally required to work from ladders, lifts or scaffolds.
- The employee is regularly required to handle tools utilizing various energy sources- low and high voltage, pneumatic, hydraulic -of low to high power.
The work environment characteristics described here are typical of those an employee might encounter while performing the essential functions of this job.
- Work is normally performed in both the office and the shop.
- The office environment is an interior office with air conditioning.
- The shop contains mobile equipment, machinery, and high voltages.
- The shop noise level is variable and may require hearing protection in some areas.
- The shop is heated when required but many areas are not air conditioned.
- Some shop processes use high voltage arcs or concentrated magnetic fields.