*Candidates must have experience with change control, change orders and quality
Description / Summary:
This role will provide support to the Regulatory Affairs organization by –
a. Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system,
b. Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance's are met,
c. Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance.
d. Driving quality system process improvement initiatives
Initiatives include but are not limited to:
1. Establishing emerging issues in our quality system,
2. Maintaining the quality system procedures (e.g. change management),
3. Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements,
4. Troubleshooting with regulatory affiliates, and
5. Participating in RA projects.
Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
List of tasks:
• CFG requests in the FDA database.
• Declarations of conformity.
• Review Regulatory Letters and maintain LoA / PoA tracker.
• Will coordinate pan-franchise requests for multiple products, schedule meetings with international requesters.
• Maintain tracker / SharePoint / folders with current state.
• Change management
Skills:
• Independent
• Troubleshooting
• Critical thinker
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously
Description:
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices;
Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
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