Tandem is an innovative medical device company launching a product with cutting edge technology and is looking for a motivated and driven Senior Regulatory Affairs Specialist. We need an experienced Regulatory professional to coordinate the preparation, review and submission of information packages to regulatory agencies. This includes 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 including all programs related to FDA and QSR compliance
What you’ll be doing:
What you need for this position:
- Support interactions 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.
- Draft direction and strategy to management for classification of new product, revised product designs and assist in the compilation of and submission of applications for clearance of new or revised product designs. Draft letters to file as applicable.
- Manage registration files, including required responses to regulatory agencies.
- Analyze 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.
- Participate on product development core teams as the regulatory representative.
- Participate and coordinates in recall meetings, as needed.
- Provide regulatory affairs tactical support for all aspects of product development and manufacturing.
- Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
- Review and provides recommendations on labeling (including advertising and promotional materials), manufacturing, and analytical and clinical study plans for regulatory compliance.
- Review and approves document and engineering change orders and prepares letters-to-file.
- Ensure 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.
- Keep informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
- Confirm completion of required training plan before assuming job responsibilities.
- Ensure work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
What’s in it for you?
- 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.
- 5 years’ Regulatory Affairs experience within a FDA regulated medical device industry including:
- 510(k) submissions for infusion devices and disposables preferred.
- FDA Electronic Registration experience preferred.
- CMDR and/or CE Mark experience. Demonstrated knowledge of US FDA regulations with specific 510(k) Class II medical device expertise.
- Knowledge of quality systems related to regulatory activities.
- 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.
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