Senior Regulatory Affairs Specialist
Medtronic
Job Level
JuniorMid-Level
About the role
- Ensures that suppliers deliver quality parts, materials, and services
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
- Provides Pre-Market Quality Engineering support to New Product Development (NPD) in partnership with Component Engineering and Post-Market Supplier Quality Teams
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle and implements strategies for driving product quality and continuous improvement
- Collaborates with Component Engineers to develop and deliver Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
- Define Receiving Inspection requirements and associated test method validation for internal Medtronic Test Methods
- Acts as technical specialist individual contributor, may mentor colleagues and manage assigned projects
Requirements
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience
- Employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees
- For sales reps and other patient facing field employees, must comply with credentialing requirements at the hospitals or clinics they support
