Senior Manager overseeing regulatory asset management and project delivery in a global biopharma company. Leading cross - functional collaboration to ensure oversight and compliance with regulatory strategies.
About the role
- Senior Compliance Engineer supporting EMC testing and compliance for new product development at Stryker Medical. Collaborating with teams to ensure regulatory compliance throughout product lifecycle.
Responsibilities
- Support electromagnetic compatibility testing and compliance activities for new product development and/or sustaining engineering.
- Develop and execute EMC test plans and support design reviews.
- Apply EMC standards and test methods for medical devices, building proficiency in IEC 60601‑1‑2 and related global requirements.
- Collaborate with design, quality, and regulatory teams to identify and resolve EMC compliance needs throughout the product lifecycle.
- Lead end-to-end EMC compliance Strategy for new product development programs and/or sustainment programs within Stryker Medical.
- Review designs with subject matter experts to develop EMC compliance plans and collaborate with design engineers to imprint good EMC design practices early in the design cycle.
- Analyze designs for adherence to good EMC design practices.
Requirements
- Bachelor’s degree in electrical engineering or related discipline.
- 2+ years of experience required.
- Experience with product safety regulatory certification for major standards bodies and frameworks (e.g., IEC, AAMI, and related schemes).
- Experience with medical device product development lifecycle, including design controls and risk management.
- Experience working with and managing third-party certification laboratories (e.g., UL, TÜV, CSA, Intertek).
- Experience with device regulatory certification involving safety, EMC, and/or wireless standards.
- Demonstrated ability to work independently and effectively in a matrixed organization.
- Strong written, verbal, and interpersonal communication skills with the ability to influence without authority.
Benefits
- Work Flexibility: Onsite
Job title
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