Manager, Regulatory Affairs

Integer • Full-time • Plymouth, MN • 2d ago

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

Who are we?

Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six Values, including focus on Customers, Innovation, Collaboration, Inclusion, Candor, and Integrity. Working at Integer means you are part of a team passionately pursuing excellence in all that we do and always reaching for the next great achievement.

What you will do in this role:

The primary purpose of this role is to manage the activities of and provide daily direction to a team of quality professionals, including any combination of regulatory affairs supervisor(s), regulatory affairs specialists, and technicians, to ensure that quality and regulatory requirements, performance goals and improvement objectives for a manufacturing site are achieved. In addition, you may lead efforts to identify potential gaps in existing systems and to drive system and regulatory improvements required to enable your department to execute at an efficient level. Your primary purpose is to execute and provide input on 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.

Build & develop teams:

You will be managing, coaching, and directing a team of regulatory professionals in support of one or more product lines or process areas across a number of manufacturing sites.
You will develop US and International regulatory strategies for product submissions, identifying needs for bench, animal, and clinical testing.
You will provide strategic input. Participates on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and direction.
As part of your role, you will prepare US and International submissions and work with government agencies and/or distributors to obtain product approval/clearance.
You will serve as an informational resource for all departments, assisting in keeping the company informed of US and International regulatory requirements. You will ensure relevant International, ISO and FDA Export requirements are met, as required, and ensure accuracy of submission information.
Initiates FDA export approval requires and product release authorizations.
You will perform reviews of ECO’s and assess the effect of product changes on US and International regulatory strategy and submissions per standard procedures.
You will be required to evaluate post-market incident reports and determine MDR requirements.
As required, you will assist with recall/retrieval documentation and other activities.
Develops and maintains regulatory status documents and submission procedures.
You must identify, investigate, evaluate and implement new methodologies associated with product quality and quality systems.
You adhere to company policies and procedures and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements as required.
As part of your responsibilities, you will establish daily/weekly/monthly objectives for your team members and ensure effective communications throughout the team. An element of these objectives includes providing active support for each of your direct reports to aspire to accomplish his/her Individual Development Plans as a roadmap to professional and personal skill’s development.
You are the first level support for resolving day-to-day issues as they are raised by members of your team and, after assessing the situation, you may seek cross functional and/or organizational support for resolution. To be successful, you will possess the technical understanding and the ability to apply procedures and concepts within your own discipline and basic knowledge of other disciplines.
As an element of our belief that we all Own Quality, you engrain a culture of quality amongst your team.
You ensure compliance with the established Quality Management System.
Your leadership style encourages teamwork and ensures accountability within your team and across the interactions your team members have with others inside and outside Integer.
You promote a diverse and inclusive work environment where your team feels supported and openly communicates opportunities and issues knowing they share a feeling of mutual trust.
Provide support of Integer’s Manufacturing Excellence and Market Focused Innovation Strategies
You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:
- Strategy Alignment through quality planning meetings, regulatory meetings and regular updates to QA RA weekly and monthly metrics, and other quality initiatives.
- Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required, ensuring regulatory requirements are fulfilled.
- Standardization through adoption of Quality Policies and procedures that are aligned to and harmonized with the enterprise (Integer) Quality Management System.
- Associate Engagement promoted through the adoption of standardized problem solving. methodologies, behavior-based safety programs, and communicating changes within the regulatory environment.
- Systems: Through the adoption and integration of the principles of built in quality and of the Enterprise Quality Procedures and international regulations and standards.
How you will be measured:
The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
Safety is our highest priority; you will be an active supporter of the Integer Environmental, Health & Safety programs.
You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
Quality - Customer Direct Complaint Rate, NCR rate, Complaint Cycle Time, CAPA Cycle Time, Supplier Performance metrics
Delivery – Achievement of scheduled tasks and milestones for assigned projects.
Cost - Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.
People – You play a key role in promoting Associate engagement. In your role, you will ensure that associate relations’ issues are handled in a timely manner.
What sets you apart:
You have earned, as a minimum, a bachelor’s degree in an engineering or related technical field and have between 7 to 10 years of experience.
You will have specialized knowledge in this role's performance e.g., EU MDR, ISO 13485, ISO 9001, PMDA, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience.
You understand what it means to lead, to take leadership actions, to create and share a coordinated vision, and to align a team to take on and resolve what needs to be done.
You possess a clear preference for working in a team environment and establishing an expectation that team comes before self.
You enjoy a fast paced and complex work environment, maintaining a calm demeanor that transcends the high energy, constantly changing manufacturing setting.
While you will have regular support and guidance from more experienced engineers, supervisors or managers, you will show the ability to work independently and collaboratively with other associates and cross-functional teams.
You demonstrate a solid technical aptitude with the ability to be an effective contributor to a team or produce results of a technical nature as an individual.
You demonstrate effective communication, both written and oral, & interpersonal skills. You reflect a bias for action, decision making and applying your problem-solving skills.
You possess a positive, can-do attitude with an underlying belief that failure is not an option.

U.S. Applicants: EOE/AA Disability/Veteran

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