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Integer Holdings Corporation · 2 weeks ago

Senior Regulatory Affairs Specialist

Plymouth, MN

Full-time

Onsite

Senior Level

$113K/yr - $166K/yr

7+ years exp

Integer Holdings Corporation is committed to a culture of customer focus, innovation, collaboration, inclusion, candor, and integrity. The Senior Regulatory Affairs Specialist will strategically plan, execute, and oversee regulatory activities necessary for obtaining and maintaining regulatory approvals, ensuring compliance with relevant FDA, EU, ISO, and other standards.

Health CareManufacturingMedicalMedical Device

Responsibilities

Adheres to Integer's Core Beliefs and all safety and quality requirements

Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing

Provides strategic input. Participates on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and direction

Prepares US and International submissions and work with government agencies and/or distributors to obtain product approval/clearance

Serves as informational resource for all departments, assisting in keeping company informed of US and International regulatory requirements. Ensures relevant International, ISO and FDA Export requirements are met, as required and ensures accuracy of submission information

Initiates FDA export approval requires and product release authorizations

Reviews ECO’s and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures

Evaluates post-market incident reports and determine MDR requirements

Assists with recall/retrieval documentation and other activities

Develops and maintains regulatory status documents and submission procedures

Identifies, investigates, evaluates and implements as appropriate new methodologies associated with product quality and quality systems

Performs other functions as required

Qualification

Regulatory submissionsFDA regulationsISO requirementsQuality systemsTechnical writingSupplier relationsSpreadsheet softwareWord-processing softwareCommunication skills

Required

Bachelor's degree in a related field

7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience

Knowledge of FDA Quality System regulations and ISO requirements

Knowledge of all applicable laws which regulate medical device manufacturers

Ability to work through difficult issues with suppliers and customers

Strong communication and technical writing skills

Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000

Skill in working with computers and experience with spreadsheet and word-processing software

Benefits

Medical

Dental

Vision

Disability

Life insurance

Adoption benefits

Parental leave

Supplemental life insurance

Critical illness

Hospital indemnity

Accident insurance

401(k) plan with company matching contributions

80 hours (10 days) of company designated holidays per year

Annual allotment of paid time off

Company

Integer Holdings Corporation

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMO) in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.

Founded in 2000

Wilmington, Massachusetts, USA

10001+ employees