Assistant/manager, Regulatory Compliance
2 weeks ago
Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova - develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
SG
Assistant/Manager, Regulatory Compliance
**Responsibilities**:
- Ensure Sennheiser products are designed and verified to comply with country-specific regulatory laws and requirements in terms of Product Safety, EMC, RF, Energy Efficiency and Environmental regulations.
- Monitor, interpret, understand product related regulations, define processes to obtain and maintain certifications, provide guidance, and conduct training to internal stakeholders.
- Prevent compliance issues by collaborating with project teams, reviewing relevant data, identifying, and resolving issues.
- Stay current with trends in latest wireless technologies and applicable regulations.
- Develop/enhance compliance related systems / processes, manage compliance documents, tools, and related templates.
- Interface with external organizations, such as: test labs, certification bodies, authorities, agencies.
- Think beyond the box and anticipate regulatory compliance challenges, proactively communicate with internal stake holders and external authorities / agencies to achieve product certification / resolve issues for win-win solutions.
- Organize compliance program by preparing Certification plan, Marking matrix for products/packaging/user guides/product leaflets, Conformity assessment according to Sennheiser internal process.
- Manage complex projects with diverse scope by research & investigation, assessment & interpretation of policy / procedures / standards / regulations.
- Perform product safety evaluations based on country-specific requirements. Review & understand schematics, specifications to support and actively participate in design reviews.
- Prepare regulatory submission documents, Review marking/labeling text on product/packaging/user guide/leaflet, test reports, certificates, and declarations.
- Coordinate and support product submissions and documentation based on regulatory changes / product changes.
- Conduct product safety risk assessments related to design, processes, recommend appropriate risk mitigation measures, including process changes and lead initiatives across the stakeholders to improve and maintain product compliance, Coordinate Product Safety Factory Audits by external party.
- Prepare Technical Construction File, update Regulatory compliance status and maintain compliance database.
- Work with global team for alignment and common approach to compliance management.
- Generate company’s response to changes and follow up with appropriate areas to ensure required changes are implemented based on regulatory and legislative changes.
- Responding to customer requests regarding regulatory compliance questions/issues.
- Other related duties as assigned.
**Pre-requisites**:
- Electrical / Electronic Engineering, Bachelor’s degree with min. 5 years or Diploma in with min. 8 years of experience in regulatory compliance under consumer electronics (A/V, ITE/ICT products) with product development environment.
- Ability to recognize opportunities to improve regulatory compliance and propose practical solutions with respect to product safety / EMC / RF and processes.
- Strong written and verbal skills to create high quality technical assessment, reports, and procedures, good communication skills and ability to engage cross-functional teams, internal stakeholders and external agencies to manage product testing and certification.
- Ability to translate safety standards clauses to technical design requirements, good understanding of electrical product safety and test methodology.
- Experience in analyzing systems, identify design weaknesses and hazards that might cause accidents, and make recommendations to resolve.
- Good knowledge of wireless technologies such as 2.4GHz SRDs, Bluetooth, WiFi 2.4 GHz/ 5 GHz, NFC, Qi technology applicable to consumer products.
- Experience in handling Lithium battery and External Power adapter certification.
- Proficient in legislation, knowledge of worldwide regulatory compliance standards, certification schemes, marking & test sample requirements, implementation processes etc.
- Creative thinking, problem solving and analytical skills to make decisions using data and prioritize solutions.
- Focused, meticulous, and willing to learn new requirements related to product compliance & regulatory affairs.
- Highly innovative, self-starter, flexible, dedicated team player and able to meet deadlines.
- Track record of taking ownership and successfully delivering results in a fast-paced, dynamic envi
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