The #1 Site for IT and Engineering Jobs - search all IT and Engineering  jobs.
Myq82k67jl0lwvf8xvn

Senior Regulatory Affairs Specialist-Remote US

Job Description


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

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

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

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

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. Initiates FDA export approval requires and product release authorizations.

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

8. Evaluates post-market incident reports and determine MDR requirements.

9. Assists with recall/retrieval documentation and other activities.

10. Develops and maintains regulatory status documents and submission procedures.

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

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.

Job Requirements

 

Job Snapshot

Location US-MN-Minneapolis
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace, Other
Apply

Company Overview

Integer Holdings Corporation

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, sexual orientation, gender identity, marital status, or any other legally recognized protected basis under federal, state or local law. Greatbatch will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel you need a reasonable accommodation pursuant to the ADA, please contact us at 716-759-5412. Learn More

Contact Information

US-MN-Minneapolis
Rena Buckley
rbuckley@t.est.great
Snapshot
Integer Holdings Corporation
Company:
US-MN-Minneapolis
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace, Other
Store Type:

Job Description


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

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

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

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

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. Initiates FDA export approval requires and product release authorizations.

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

8. Evaluates post-market incident reports and determine MDR requirements.

9. Assists with recall/retrieval documentation and other activities.

10. Develops and maintains regulatory status documents and submission procedures.

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

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.

Job Requirements

 
Mwr1k875wzts0yxgjcl
Sologig Advice

For your privacy and protection, when applying to a job online: Never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn More

By applying to a job using sologig.com you are agreeing to comply with and be subject to the workinretail.com Terms and Conditions for use of our website. To use our website, you must agree with theTerms & Conditionsand both meet and comply with their provisions.
Senior Regulatory Affairs Specialist-Remote US Apply now