Senior Regulatory Affairs Specialist
About the role
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do:
- Customer – We focus on our customers’ success
- Innovation – We create better solutions
- Collaboration – We create success together
- Inclusion – We always interact with others respectfully
- Candor – We are open and honest with one another
- Integrity – We do the right things and do things right
The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
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 and participates on Product Development teams, offering a high level of experience in regulatory strategy, timelines, and direction.
- Prepares US and International submissions and works with government agencies and/or distributors to obtain product approval/clearance.
- Serves as an informational resource for all departments, assisting in keeping the company informed of US and International regulatory requirements.
- Ensures relevant International, ISO, and FDA Export requirements are met and ensures accuracy of submission information.
- Initiates FDA export approval requirements and product release authorizations.
- Reviews ECO’s and assesses the effect of product changes on US and International regulatory strategy and submissions per standard procedures.
- Evaluates post-market incident reports and determines 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.
Requirements
- Minimum Education: Bachelor’s degree in a related field.
- Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, including FDA, MDD, PMDA, TGA, and TPD experience.
Skills
- 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.
- Proficiency with computers, spreadsheet, and word-processing software.
Pay
Salary range: $113,025 – $165,770
Benefits
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including:
- Medical, dental, vision, disability, and life insurance
- Adoption benefits
- Parental leave available after one year
- Optional employee-paid programs: supplemental life insurance, critical illness, hospital indemnity, and accident insurance
- Immediate eligibility to participate in the 401(k) plan with company matching contributions
- 80 hours (10 days) of company-designated holidays per year plus an annual allotment of paid time off