Regulatory Affairs Specialist




Company Name:

Tandem Diabetes Care, Inc

Job Location:

San Diego, CA

Position Title:

Regulatory Affairs Specialist

Position Type:

Full time

General Job Description


Responsible for the independent preparation and maintenance of domestic and international regulatory filings to meet corporate objectives and for the timely completion of other assigned activities related to regulatory support activities. Prepares, reviews, and submits applications and other filings to various regulatory agencies. Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises.


Responsibilities:

Provides regulatory affairs support for all aspects of product development and manufacturing.

Reviews and approves document change orders and determines regulatory strategies for each change.

Prepares letters-to-file as needed for change orders that require them.

Prepares regulatory submissions for new product clearances/approvals including PMAs, 510(k)s, dossiers, technical files, etc.

Independently interacts with various departments throughout the company with future regulatory submissions in mind and to ensure compliance.

Responsible for regulatory compliance activities such as manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc.

Ensures compliance with applicable domestic and international regulations related to Risk Management and Medical Device Reporting.

Assists in hosting inspections from various regulatory agencies.

Takes an active role in both internal/external audits.

Keeps informed of current regulations, standards, policies, and guidance that impact the company’s regulatory methods.

Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.


Qualifications:


Bachelor’s degree or equivalent combination of education and applicable job experience, Master’s degree preferred.

2+ years of experience working in an FDA regulated industry.

Demonstrated ability to: work independently, accurately, follow instructions and schedules, and handle multiple priorities.

Excellent technical writing, editing, and proofreading skills.

Able to apply basic scientific principles to analyze and develop persuasive speech and writing.

Skilled at analytical problem solving and communicating with diverse groups.

Works on multiple assignments in collaboration with various department system owners.

Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

Skilled at promoting team cooperation and a commitment to team success.

Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary. Skilled with MS Office applications, Adobe Acrobat, document control applications, and other computer based applications.

Demonstrated knowledge of 21 CFR 814, 21 CFR 820, and other FDA guidance.


Application Information & Contact (How to Apply)


Apply to career site


Tags: