Integer Holdings Corporation
Senior Regulatory Affairs Specialist
Integer Holdings Corporation, Minneapolis, Minnesota, United States, 55447
Senior Regulatory Affairs Specialist page is loaded## Senior Regulatory Affairs Specialistlocations:
Plymouth, MNtime type:
Full timeposted on:
Posted Todayjob requisition id:
R33075By 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 rightThe 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.
Other: Skill in working with computers and experience with spreadsheet and word-processing
software.Salary range $113,025 - $165,770Our 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.**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. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical and Lake Region Medical. Additional information is available at .Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via TalentAcquisition@integer.net so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in toFor remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.**To review the Integer U.S. Applicant Privacy Statement click****.** #J-18808-Ljbffr
Plymouth, MNtime type:
Full timeposted on:
Posted Todayjob requisition id:
R33075By 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 rightThe 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.
Other: Skill in working with computers and experience with spreadsheet and word-processing
software.Salary range $113,025 - $165,770Our 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.**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. As a strategic partner of choice to medical device companies and OEMs, Integer is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company's brands include Greatbatch Medical and Lake Region Medical. Additional information is available at .Integer Holdings Corporation (“Integer”) is an equal opportunity employer. We do not discriminate based on race, color, sex, religion, national origin, and on any other protected characteristics. We celebrate our many differences and remain committed to providing an inclusive workplace free from harassment and discrimination.Integer does not discriminate against any applicants or employees because he or she is a disabled veteran, Armed Forces service medal veteran, recently separated veteran, or active-duty wartime veteran, campaign badge veteran, referred to collectively as "Protected Veterans." It is also the policy of Integer to employ and to advance in employment, all people regardless of their status as individuals with disabilities. All employment decisions are based only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship, at all levels of employment.Additionally, Integer provides reasonable accommodations to qualified job applicants and associates who need them for medical or religious reasons. If you are interested in applying for an employment opportunity with Integer and believe you will need an accommodation for the application or job interview processes, please contact us at +716-759-5631 or via TalentAcquisition@integer.net so that we may discuss appropriate adjustments to our processes to enable you to be considered for a job opening. This phone number and email address is strictly for the purpose of making a request for an accommodation. Status updates on your application cannot be provided to you through this phone extension or email. For status updates, please log in toFor remote eligible job postings, all work should be performed entirely outside of Alaska, California, Hawaii, Maine, Montana, and Washington.**To review the Integer U.S. Applicant Privacy Statement click****.** #J-18808-Ljbffr