Associate Director Regulatory-Remote
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
About the Division
ImmunoDiagnostics is the global leader in allergy and autoimmunity diagnostics. Our mission is to dramatically improve the management of allergy, asthma, and autoimmune diseases by providing healthcare professionals with advanced diagnostic technologies and clinical expertise.
By striving to meet these goals, we can both offer healthcare professionals and patients around the world the benefits of predictive ability and earlier diagnosis. But the real results are in better patient care – and in improving people’s everyday lives.
How Will You Make An Impact?
You’ll be responsible for providing strategic direction and leadership for regulatory to our commercial organization, to maintain and proactively improve the quality system, and to assure product compliance towards local regulations applicable to our products and services. You’ll also provide regulatory and quality insights and guidance on new product introduction, marketing initiatives and long-range planning for the Immunodiagnostics Division (IDD).
What Will You Do?
Regulatory Affairs and Post Market Surveillance
- Oversee new and updates to current regional specific regulations relevant for the product lines distributed, and assure the Centers of Excellence are made aware of such updates
- Engage in the development and maintenance of the product regulatory strategy for the region
- Participate in the review process of product submissions prepared by the development functions at a Center of Excellence.
- Act as liaison with authorities for product registration submissions, support an efficient review process as well as timely responsiveness to queries
- Manage effectively customer feedback as part of the Post Market Surveillance processes.
- Act as liaison with authorities for product surveillance matters and co-operate with the implementation of any field actions initiated from the manufacturing site.
- Drive proper communication and distribution to colleagues as well as customers upon execution of any required field action. Secure follow-through, completion, and reporting.
- Assist in the approval of all local promotional material prior to use.
- Represent the company in any contact with local authorities responsible for regulation and surveillance of product safety.
Quality System Management
- Assure local quality systems are compliant with all relevant regulations and agreements at all times.
- Maintain quality manual and procedures, ensuring alignment across the commercial functions and manufacturing units.
- Ensure control of records and documents of the quality management system and its processes.
- Supervise, monitor and review quality-related processes, such as Complaint Management; Servicing, Installation and Post Market Surveillance.
- Drive the process of Corrective Action, Preventive Action (CAPA) and continuous improvement
- Assure appropriate quality agreements are established and maintained between the commercial unit and the manufacturing sites.
- Enable collaborative relationships between internal stakeholders with the overall focus on improving customer satisfaction and compliance.
- Develop, manage, deliver and monitor training related to the quality system.
- Manage internal and external quality audits to ensure compliance with external local regulations as well as internal quality agreements.
- Be the main point of contact for surveillance and re-certification audits performed by the relevant agencies.
- Model leadership behaviors which embody our values, delighting customers, communicating openly and honestly, focus on growth, and champion employee development.
- Lead, mentor, coach, and develop a team of Quality & Regulatory professionals including talent selection, development, performance management and process improvement.
- Drive the management review process which includes ensuring management awareness of compliance state, changes in legislation and reporting quality metrics to key stakeholders.
- Being a member of the global IDD QARA Leadership team, actively participate in developing and driving the long-term strategy for the function.
How will you get here?
- A Bachelor’s degree or equivalent in a relevant technical subject (e.g. chemistry, biochemistry, pharmacy or engineering). MBA or advanced degree preferred.
- A minimum of 7 years of experience in Quality or Regulatory with a minimum of 3 years of experience administering quality systems such as complaint management, CAPA, training, etc.
- Previous experience from a regulated work environment, preferably within the medical device or diagnostic industry.
- Experience working with U.S. Customs Import and Export Regulations preferred.
Knowledge, Skills, Abilities
- Quality and compliance knowledge of working with ISO 13485 and/or FDA 21 CFR 820.
- Able to work independently, taking responsibility for the management of processes, projects, and timelines.
- Capability to lead change and work across departments to implement new procedures and programs.
- Ability to drive results in a matrix organization.
- Certification / documented training in auditing of quality systems; e.g. ISO 13485 and/or QSIT technique.
- Demonstrated Leadership capabilities, with experience in supervising and leading teams to a successful outcome.
- Ability to travel 30% domestically and to travel internationally 3-4 times a year.
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.