This position is responsible for all Regulatory affairs for medical devices and hearing related products. This includes the strategy of how products are viewed in our world-wide markets by various regulatory agencies. This position will work with various departments across the organization such as Sales and Marketing to the Product Development group to ensure all regulatory requirements are known and understood throughout the product life cycle. This position is responsible to keep current with all changes to medical device regulations to ensure Starkey products comply to all new or changing requirements, including labeling. This position is also responsible for creating and maintaining the technical file for all medical devices and hearing related products.
Ensure market access of our products World-Wide
Assess the acceptability of quality, and clinical documentation for submission filling to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval
Generate and approve labeling for compliance before release
Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information
Coordinate Homologation device delivery, testing & registration within new markets
Compile, prepare, review and submit regulatory submission to authorities
Provide regulatory input to product lifecycle planning
Maintain records to comply with regulatory requirements
Ensure wireless requirements are understood for each market and communicated throughout the product development process.
Identify Product Risk within product development (per project) and work with others to mitigate
Ensure product safety issues and product-associated events are reported to regulatory agencies
Participate in risk-benefit analysis for regulatory compliance
Manage global Regulatory threats, changes and opportunities
Periodically scan changes in standards, regulations, guidance and events in the areas of Medical Devices, Radio Devices, Noise Protection Devices, or Environmental.
Provide training for staff on current and new regulatory requirements
Communicate regulatory agency/industry positions within the regulatory department
Participate in professional associations, industry/trade groups (local/regional/international) and appropriate standards organizations
Results – Performance Measures (How to Measure Success)
On-time completion of homologation testing and on-time market access (each product release, ~6 months)
On-time completion of product registration for international markets (as requested by IBD/Sales)
On-time completion and approved 510k or other submissions where required (annually)
Timely completion of technical file documents, prior to market release (each product release, ~6 months)
Accurate completion of technical file documents, prior to market release (each product release, ~6 months)
No impact to Starkey Sales due to changes in any regulatory environment (annually)
Minimum education, certification and experience requirements:
Four-year degree in Engineering or Science. Master’s degree (MS, MBA) preferred.
Sr Regulatory Affairs Engineer I: Minimum 7 years with B.S. or related experience, or 5 years with M.S., or 2 years with PhD
Sr Regulatory Affairs Engineer II: Minimum 10 years with B.S. or related experience, or 8 years with M.S., or 5 years with PhD
GxPs (GCPs, GLPs, GMPs)
Knowledge of Quality Management Systems
Knowledge of World Wide regulatory requirements
Knowledge of product marking requirements (by market)
Skills & Abilities
Strategic Planning and organizing
Written and verbal communication
Communicate with internal stakeholders and regulatory authorities
Prepare applications and regulatory documentation
Review and assess regulatory submissions
Utilize electronic submission techniques
Critical thinking and problem solving
Good attention to detail
Systems analysis skills desired
Exercise of authority or supervision over others:
This position may have 1-2 other professionals reporting to them.
This position has access to a variety of confidential personnel and company data. This position requires the highest level of moral and ethical standards.
Communicates with vendors & Various Regulatory bodies
Normal office conditions
Some travel is possible <10%
Additional Salary Information: 0
Internal Number: 27535
About Starkey Hearing Technologies
Starkey Hearing Technologies is a world leader in the design, development and distribution of comprehensive hearing solutions. We believe in using superior hearing technology to create meaningful connections between people and their worlds.
Connections are also created between Starkey Hearing Technologies and our employees. Review the benefits of employment at Starkey Hearing Technologies to see what makes this a unique and exciting place to work.