Regulatory Compliance Specialist

2 weeks ago

Singapur, Singapore Sonova Full time
Senior/Regulatory Compliance Officer

About the Role:

We are seeking a highly motivated and experienced Senior/Regulatory Compliance Officer to join our team at Sonova. As a key member of our regulatory compliance team, you will be responsible for ensuring that our products comply with country-specific regulatory laws and requirements.

Key Responsibilities:

  • Develop and implement compliance strategies to ensure product safety, EMC, RF, and environmental regulations are met.
  • Monitor and interpret product-related regulations, define processes to obtain and maintain certifications, and provide guidance to internal stakeholders.
  • Collaborate with project teams to prevent compliance issues, review relevant data, identify, and resolve issues.
  • Stay current with trends in latest wireless technologies and applicable regulations.
  • Develop and enhance compliance-related systems, manage compliance documents, tools, and related templates.
  • Interface with external organizations, such as test labs, certification bodies, authorities, and agencies.
  • Anticipate regulatory compliance challenges, proactively communicate with internal stakeholders and external authorities/agencies to achieve product certification and resolve issues.
  • Organize compliance programs, prepare certification plans, marking matrices, and conformity assessments according to Sonova's internal process.
  • Coordinate and support product testing and application processes with outside agencies/authorities to gain successful market access and timely introduction of new products.
  • Manage complex projects with diverse scope, research, and investigation, assessment, and interpretation of policies, procedures, standards, and regulations.
  • Perform product safety evaluations based on country-specific requirements, review and understand schematics, specifications, 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, and lead initiatives across stakeholders to improve and maintain product compliance.
  • Coordinate product safety factory audits by external parties.
  • Prepare Technical Construction Files, update Regulatory Compliance Status, and maintain compliance databases.
  • Work with global teams for alignment and common approach to compliance management.
  • Generate company responses to changes and follow up with appropriate areas to ensure required changes are implemented based on regulatory and legislative changes.
  • Respond to customer requests regarding regulatory compliance questions/issues.

Requirements:

  • Bachelor's degree in Electrical/Electronic Engineering or Diploma in a related field with a minimum of 5 years or 8 years of experience in regulatory compliance under consumer electronics (A/V, ITE/ICT products) in product development environments.
  • 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 assessments, reports, and procedures, good communication skills, and ability to engage cross-functional teams, internal stakeholders, and external agencies to manage product testing and certification.
  • In-depth understanding and well-versed to apply product safety requirements for Class I, II, and III equipment based on IEC60065/60950/ standards, Energy/Power source classifications, LPS, Insulation & Isolation, clearances and creepage distances, leakage current, thermal requirements, electric strengths, Fire enclosure, Flammability class, etc. to A/V, ITE/ICT products.
  • 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/5GHz, 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, and 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 motivated, self-starter, flexible, dedicated team player, and able to meet deadlines.
  • Track record of taking ownership and successfully delivering results in a fast-paced and dynamic environment.
  • Process-oriented with high attention to details and proven ability to manage multiple, competing priorities simultaneously.
  • Passionate about product compliance work, willing to take challenges, share/coach others.
  • Able to develop intercultural collaboration.
  • Good knowledge and deep understanding in Product Safety, EMC & RF regulations and process for main countries in EMEA, North America, Latin America, APAC for consumer A/V or ITE/ICT products.
  • Knowledge of test methodologies and test equipment used for regulatory compliance tests.
  • Hands-on with Bluetooth Qualification Process and SIG Listing.
  • Knowledge of Environmental Regulations such as ErP, MEPS, RoHS, REACH, TSSA, Battery Directive, Packaging Directive, etc.
  • Troubleshooting techniques related to compliance issues is added value.
  • Usage of Product Data Management System (example: CIM Database or others).

What We Offer:

At Sonova, we offer a dynamic and challenging work environment, competitive compensation and benefits package, and opportunities for professional growth and development.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and cover letter, to [insert contact information].

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