Sr Director, Regulatory Affairs

Tandem Diabetes Care Switzerland Sarl

  • Saint-Sulpice, Vaud
  • CDI
  • Temps-plein
  • Il y a 1 jour
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. 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. Tandem is always looking to add talent that can help us manage our interests globally.STAY AWESOME:Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with -IQ technology — an advanced predictive algorithm that automates insulin delivery.But we’re so much more than that. Our company’s human-centered 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 atA DAY IN THE LIFE: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 ISOThe 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.Working as Sr Director, Regulatory Affairs, International, you will...
  • Provide leadership, vision, and innovative ideas for developing and improving Tandem’s Regulatory Strategy.
  • Partner with business and product leaders to provide regulatory strategies and country assessments of new markets.
  • Provide leadership support to the regulatory team.
  • Develop strategic and tactical plans for all regulatory submissions including filings, ensure completeness, administrative and scientific accuracy; facilitate timely
government approvals for marketing new and modified products. * Provide 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.
  • Support interactions with regulatory agencies and lead 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.
+ Build direction and strategy to manage 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. * Partner with CRA for clinical trial designs including the monitoring and preparation of submissions for clinical studies.+ Participate in product development core teams as the regulatory representative. * Provide regulatory affairs tactical support for all aspects of product development and manufacturing.
  • Review and provide recommendations on labeling (including advertising and promotional materials), manufacturing, and analytical and clinical study plans for regulatory compliance.
  • Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
  • Oversee and guide a variety of personnel actions to include, but not limited to, hiring, performance appraisals, merit recommendations and promotions.
  • Direct long and short-term planning for the department including headcount, budgeting, training, and systems requirements.
  • Ensure work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
WHAT YOU’LL NEED:
  • 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”, ISOrequirements, 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.
EXTRA AWESOME:
  • 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.
  • + 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, preferred.
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