Regulatory Affairs Specialist III

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.

We focus on our customers’ success

We create better solutions

We create success together

We always interact with others respectfully

We are open and honest with one another

We do the right things and do things right

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.

The primary purpose of this job is to provide team support to Regulatory Affairs managers and department management in being responsible for ensuring compliance to all relevant regulations and standards. Develop strategies and prepare submissions for national and international product registrations. Prepares and maintains regulatory files, regulatory reports, and databases.

• You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to:
  Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

• You will be responsible to prepare national and international regulatory submissions for Integer owned devices. You will provide team support and leadership for product submissions and consult with multiple sources for information in order to to prepare submissions.
• You will review Change Requests that require regulatory review and approval to ensure compliance with national and international government regulations.
• You will prepare and maintain no-file decisions, external regulatory databases (ex. FDA FURLS, GUDID, EUDAMED, etc.), and product files consistent with Integer quality system requirements and department procedures.

• You will actively support the sales and marketing team and develop regulatory strategies where required
• You will actively support projects from new product introduction (NPI) and R&D and develop regulatory strategies
• You will participate in risk management activities,
• You will attend project meeting attendance and provide regulatory assessments and required technical feedback, as required.

• You will coordinate the review of and responses to customer requests/queries for information related to process and products and maintain respective tracking logs.
• You will participate in customer notification of changes and assist in maintaining respective tracking log.
• You will obtain external regulatory documents in support of customer requests (ex. CFG’s, CFS’s) and facilitate the legalization/authentication/apostilling of such documents, as required.

• You may perform and support internal quality system audits in accordance with Integer quality management system procedures and according to the external requirements as indicated in the Integer Quality Manual.
• You will participate in regulatory and Notified Body audits as a regulatory team member in either back room or front room activities and may compile, organize and track responses to findings.

• You will perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.
• You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in…