Sr Regulatory Affairs Specialist II
Sr Regulatory Affairs Specialist II
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$ 114000 - 135000
1 Vacancy
Job Description
GROW WITH US:
Tandem Diabetes Care creates new possibilities for people living with diabetes their loved ones and their healthcare providers through a positively different experience. Wed love for you to team up with us to innovate every day put people first and take the noshortcuts approach that has propelled us to become a leader in the diabetes technology industry.
STAY AWESOME:
Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control IQ technology an advanced predictive algorithm that automates insulin delivery. But were so much more than that. Our companys humancentered approach to design development and support delivers innovative products and services for people who use insulin. Because many of our own team members live with type 1 diabetes or have a loved one impacted by diabetes the work is personal and we are committed to the cause. Learn more at DAY IN THE LIFE:
The Sr. Regulatory Affairs Specialist II is responsible for developing strategies for worldwide regulatory approval to introduce new products to market maintaining existing products providing advice on regulatory requirements preparing worldwide submissions and negotiating their approval with the agencies. As a subject matter expert this role drives continuous improvement of key business and regulatory processes to ensure compliance with regulations set forth by the USFDA International Regulatory Agencies and in conformance with Good Manufacturing Practices 21CFR Part 820 21CFR Part 803 21CFR Part 806 European MDD MDR and ISO 13485. Prior experience with SaMD MDDS AI/ML nonSaMD and Digital Healthcare is highly desired for this role.
YOURE AWESOME AT:
- Provides regulatory strategy to meet requirements from product ideation to premarket submissions/registrations product launch and post market compliance working closely with healthcare regulatory bodies globally (including EU & UK).
- Interprets Medical Device regulations with a particular emphasis on Digital Health Software as a medical device (SaMD) Cybersecurity AI/ML enabled devices and provide direction to product teams in understanding the impact of such regulations on existing and new Digital Health products and solutions.
- Serves as a lead on product design/development and sustaining engineering project teams. Reviews and approves change orders as well as provides regulatory input to support closure (IMS updates Procedural changes etc.
- Identify gaps in product development plans that may pose regulatory issues and come up with novel development strategies.
- Provides regulatory input on promotional and advertising activities.
- Ensures compliance with company policies including Privacy/HIPAA and other legal and regulatory requirements.
- Acts as Tandem representative in FDA and other regulatory inspections as needed.
- Reviews and Complete US and OUS submissions as directed; liaising with the health authorities as needed.
EXTRA AWESOME:
- Bachelors degree in Science Regulatory Affairs Technology Engineering or Mathematics or equivalent combination of education and applicable job experience.
- Regulatory Affairs Certificate preferred.
- 7 years of related experience in regulatory function in medical device or health IT industry.
- Demonstrated experience in leading designing writing and submission of regulatory filings and correspondence and/or approvals including experience authoring a range of global regulatory submissions (e.g. 510(k) De Novo CE Mark etc. and preparing regulatory submissions to support product commercialization (e.g. 510(k) CE Mark Technical File International).
- Proficient knowledge of quality standards: ISO 9001 ISO 13485 ISO 14001 ISOCFR Part 820 and other appropriate industry standards.
- Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
- Significant experience with products containing software including knowledge of the software life cycle.
- Working knowledge of IEC 60601series standards specifically IEC 62304.
- Prior experience with SaMD MDDS AI/ML nonSaMD and Digital Healthcare.
- Ability to translate and simplify technical content or regulations and communicate to stakeholders.
- Strong understanding of policy laws regulations and guidelines as they apply to Regulatory Agencies globally for diagnostic/digital health tool development and approval with particular focus on US and EU/UK.
- Demonstrated experience communicating with regulatory agencies including FDA Health Canada and EU regulatory agencies.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the product development and commercialization process.
- Ability to recognize nonconformances from accepted and documented practices.
- Skilled at clearly conveying indepth knowledge to all levels within and outside of the organization.
- Skilled at creating a cooperative team environment.
- Ability to dive into details translate and statistically analyze data and effectively report results through written and/or graphical formats.
- A positive approach to people and problem solutions along with a strong sense of discretion and the ability to maintain confidentiality.
WHATS IN IT FOR YOU
In addition to innovative technology we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forwardthinking achievers to join our workforce; we reward develop and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit YOU WITH US!
We embrace the value that every single one of us brings to the table. But sometimes we forget that when we dont meet 100 of a job descriptions criteria maybe youre feeling that way right now We encourage you to apply anyway. Because we want you to be you with us.
Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age disability sex race religion or belief gender identity or expression marriage/civil partnership pregnancy/maternity or sexual orientation. We are an inclusive organization and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.
COMPENSATION & BENEFITS:
The starting base pay range for this position is $114000 $135000annually. Base pay will vary based on jobrelated knowledge skills experience and may also fluctuate depending on candidates location and the overall job market. In addition to base pay Tandem offers a competitive compensation package that includes bonus equity and a robust benefits package.
Tandem offers health care benefits such as medical dental vision available your first day as well as health savings accounts and flexible saving accounts. Youll also receive 11 paid holidays per year a minimum of 20 days of paid time off (with accrual starting on day 1 and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandems benefits here!
WHY YOULL LOVE WORKING HERE:
At Tandem we believe joy fuels excellence. Thats why weve built a workplace that celebrates your achievements and supports your wellbeing. Our team thrives on pushing boundaries and fostering growth all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at Make a move that matters. Join Tandem Diabetes Care where were turning challenges into triumphs every day and where your talents will help shape a healthier happier tomorrow.
YOU SHOULD KNOW:
Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a preemployment screening process comprised of a drug test (excluding and background check which includes a review of criminal history information.
Tandem has good cause to conduct a review of criminal history information of candidates for this position as this role may involve access to proprietary sensitive and/or confidential information including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers employees and stakeholders.
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
REFERRALS:
We love a good referral! If you know someone who would be a great fit for this position please share!
If you are applying for this job and live in California please read Tandems CCPA Notice:
#LIHybrid #LIDW1
Required Experience:
Senior IC
Employment Type
Full-Time
