Senior Regulatory Affairs Specialist

Regulatory Toolkit; Plymouth (MN); Sur place; USD 113 000 - 166 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision

401(k) with company match

Parental leave after one year

Adoption benefits

Paid time off

Résumé du poste

Integer is seeking an experienced Regulatory Affairs professional to strategically plan, execute, and oversee regulatory activities for US and international markets. You will ensure compliance with FDA, EU ISO standards and other regulatory requirements, coordinating with Product Development to guide submissions and timelines.

The role demands 7+ years of medical device regulatory experience and strong writing/communication skills.

Qualifications

• Minimum Education: Bachelor’s degree in a related field.
• Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience.
• Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements.; Knowledge of applicable laws regulating medical device manufacturers.
• Special Skills: Strong communication and technical writing skills; skills in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000.
• Other: Proficiency with spreadsheets and word-processing software.

Responsabilités

• 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 with regulatory experience in strategy, timelines, and direction.
• Prepares US and International submissions and works with government agencies and/or distributors to obtain product approval/clearance.
• Serves as informational resource for all departments, ensuring compliance with International, ISO and FDA export requirements.
• Initiates FDA export approvals as required and product release authorizations.
• Reviews ECOs and assesses effects of product changes on regulatory strategy and submissions.
• Evaluates post-market incident reports and MDR requirements.
• Assists with recall/retrieval documentation and other activities.
• Develops and maintains regulatory status documents and submission procedures.
• Identifies, investigates and implements new methodologies for product quality and quality systems.
• Performs other functions as required.

Connaissances

Strong communication

Technical writing

Management

Auditing

Supplier relations

Formation

Bachelor’s degree in a related field

Outils

Spreadsheet software

Word processing

Description du poste

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.

Key Accountabilities and Responsibilities

1. 1. Adheres to Integer's Core Beliefs and all safety and quality requirements.
2. 2. Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
3. 3. Provides strategic input. Participates on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and direction.
4. 4. Prepares US and International submissions and work with government agencies and/or distributors to obtain product approval/clearance.
5. 5. 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.
6. 6. Initiates FDA export approval requires and product release authorizations.
7. 7. Reviews ECO’s and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures.
8. 8. Evaluates post-market incident reports and determine MDR requirements.
9. 9. Assists with recall/retrieval documentation and other activities.
10. 10. Develops and maintains regulatory status documents and submission procedures.
11. 11. Identifies, investigates, evaluates and implements as appropriate new methodologies associated with product quality and quality systems.
12. 12. Performs other functions as required.

Job Requirements

Minimum Education: Bachelor’s degree in a related field.

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

Specialized Knowledge:

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.

Special Skills:

Strong communication and technical writing skills. Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000.

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

Salary range $113,025 - $165,770

#IND1

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, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.