Sr. Director, Regulatory Affairs

GROW WITH US:

Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company which creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience and is based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.

Join Our Team as Sr Director, Regulatory Affairs, International!

The Senior Director, Regulatory Affairs is responsible for leading the development and execution of the company’s Regulatory strategies. Success will be demonstrated through a strong knowledge of FDA and international guidance and regulations. As a Senior Director, this role acts as a liaison with business leadership to ensure that new market regulatory strategies are defined and implemented. The role acts as a subject matter expert for regulatory processes for Tandem products requiring FDA and OUS agency approvals by ensuring that all necessary applications and submissions are filed accurately and timely. As an RA leader, this role drives the continuous assessment and 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. The Senior Director plays a key role in the Regulatory Affairs continuous improvement program, defining the program’s goals, developing systematic problem solving and management techniques, and facilitating team activities. Additionally, the role prepares the regulatory organization for the challenges that come with rapid global growth as Tandem becomes a world market leader in high quality, leading edge, diabetes care products. 

PRIMARY DUTIES & RESPONSIBILITIES:

• Provides leadership, vision, and innovative ideas for developing and improving Tandem’s Regulatory Strategy
• Partners with business and product leaders to provide regulatory strategies and country assessments of new markets.
• Provides leadership support to the regulatory team.
• Develops strategic and tactical plans for all regulatory submissions including filings, ensures completeness, administrative and scientific accuracy; facilitates timely government approvals for marketing new and modified products.
• Provides regular and timely status updates and data to Tandem leadership regarding regulatory and new product development and existing product enhancements, and other Regulatory topics, as needed.
• Supports 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.
• Builds direction and strategy to manage classification of new product, revised product designs and assists in the compilation of and submission of applications for clearance of new or revised product designs. Drafts letters to file as applicable.
• Partners with CRA for clinical trial designs including the monitoring and preparation of submissions for clinical studies.
• Participates in product development core teams as the regulatory representative. Provides regulatory affairs tactical support for all aspects of product development and manufacturing.
• Reviews and provides recommendations on labeling (including advertising and promotional materials), manufacturing, and analytical and clinical study plans for regulatory compliance.
• Supports regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
• Oversees and guides a variety of personnel actions to include, but not limited to, hiring, performance appraisals, merit recommendations and promotions.
• Directs long and short-term planning for the department including headcount, budgeting, training, and systems requirements.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Other responsibilities as assigned.

Knowledge, skills & abilities:

• Proficient knowledge of US FDA, EMEA, Latin America, Asia Pacific and international guidelines
• Demonstrated knowledge and understanding of FDA Good Manufacturing Practices “GMP” and Quality System Regulations “QSR”, ISO 9000 requirements, and in developing the systems and teams to operate effectively within these requirements.
• Proven leadership skills, team-building and mentoring skills, a track record of building, leading, and working on teams, ability to coach both peers and subordinates effectively.
• Excellent communication skills, ability to communicate effectively both orally and in writing, to establish and maintain cooperative working relationships with persons inside and outside the business, and the ability to make effective and persuasive presentations both internally and externally.
• Professional presence, ability to represent the Company and the department internally and at business functions in a competent and professional manner.
• Knowledge of computer applications (Microsoft Word, Excel, PowerPoint, Access & Project Windows, Visio, etc.) is required.
• Thorough knowledge of global regulations.
• Strong knowledge of lean manufacturing processes, computer and equipment qualification, validation, GMPs, ISO, and product/process validation.
• Adept at negotiating with notified bodies, vendors, and management and influencing senior level leaders regarding matters of significance to the organization.

• Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals
  

WHAT WE'RE LOOKING FOR:

• Bachelor’s degree (B.A/B.S.) in Health Sciences or Engineering or combination of equivalent education and applicable work experience.
• Master’s Degree, ideally in a related engineering or Health Science discipline, preferred.
• Regulatory Affairs Certification (RAC) preferred.

Minimum experience:

• 12 years of experience in Regulatory Affairs, preferably in the medical device industry.
• 8 years of experience in a Regulatory Affairs management role.
• Global regulatory submission experience with Class I, II and III device environments.
• Knowledge with infusion pumps

WHY JOIN US?

• Be a key contributor to a rapidly growing organization.
• Work independently with minimal supervision.
• Collaborate with diverse teams across multiple jurisdictions and cultures.
• Drive process improvements and implement strategic initiatives.
• [Ready to make a global impact /patient health journeys/improve lives etc]

JOB SCOPE:

• Recognized as an influential leader, provides strategy and direction for major functional area(s). Directs and controls activities through skilled managers who have overall responsibility for a designated work section.
• Consistently works with abstract ideas or situations across functional areas of the business.
• Erroneous decisions will have a long-term effect on the company's success.

WHAT’S 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 forward-thinking 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 https://www.tandemdiabetes.com/careers .

BE YOU, WITH US!

Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

REFERRALS:

We love a good referral! If you know someone that would be a great fit for this position, please share!

If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants .

 APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

#LI-Remote #LI-BC1