Tandem is an innovative medical device company launching a product with cutting edge technology and is looking for motivated and driven people who share our passion. To become an industry leader, we need a passionate individual responsible for the 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. Our Regulatory Affairs Specialist will coordinate the preparation, review and submission of information packages to regulatory agencies. Provides regulatory guidance for labeling, manufacturing processes and analytical/clinical studies.
What you'll be doing:
Interacts closely with regulatory agencies and leads preparation of US regulatory submissions for new product approvals including 510(k)s, technical files and regulatory filings such as CE-mark declarations of conformity as appropriate.
Manages registration files, including required responses to regulatory agencies.
Analyzes and makes recommendations regarding complaints received by the company and whether they are MDR or vigilance reportable; participates in complaint investigations and CAPA meetings as appropriate.
Participates on product development core teams as the regulatory representative.
Participates in supplier complaint/recall meetings, as needed.
Provides regulatory affairs tactical support for all aspects of product development and manufacturing.
Supports regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
Reviews and provides recommendations on labeling (including advertising and promotional materials), manufacturing, and analytical and clinical study plans for regulatory compliance.
Reviews and approves document change orders and prepares letters-to-file.
Ensures applicable domestic and international regulations, related to Risk Management and Medical Device Reporting, are met.
Assist in hosting inspections, as needed.
Assist in conducting internal/external audits, as needed.
Keeps informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
Confirms completion of required training plan before assuming job responsibilities.
Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
Performs other related duties and tasks, as required.
What you'll need for this position:
Demonstrated knowledge of US FDA regulations with specific 510(k) Class II medical device expertise.
Knowledge of quality systems related to regulatory activities.
Overall understanding of international medical device regulations with specific knowledge of Canadian Medical Device Regulations and EU CE Mark.
Excellent technical writing, editing, and proofreading skills.
Skilled at analytical problem solving and communicating with culturally 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 as well as Adobe Acrobat, etc.
Bachelor's degree in a related technical field or equivalent education and applicable work experience.
Certification (RAC) by the Regulatory Affairs Professional Society is desirable.
FDA Electronic Registration experience.
What's in it for you?
Competitive base salary combined with option grants, great work environment, and generous benefits.
Opportunity to work with a team that is committed to improving the lives of people with diabetes.
To be a part of a company where you are empowered to 'get it done' through the removal of barriers and the reward of nimble behavior.
Tandem Diabetes Care, Inc. - 19 months ago