Sr Manager, Regulatory Clinical Research

Covid Protocol:

Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all of our newly-hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.

What you’ll do:

The leader for regulatory clinical research is responsible for developing and managing the regulatory clinical research team. They manage clinical trials that support regulatory approval of new to world products and product claims. They collaborate closely with marketing and technical functions to define these studies, maintain scope, while ensuring alignment with new product development. This role is further responsible for the team’s compliance with local and global regulations.

• Maintain expert familiarity with applicable regulations and standards that apply to clinical trials completed in the United States

• Contribute to clinical strategies that enable future product authorization

• Manage pre- and post-approval clinical trials including compliance to regulatory requirements

• Manage site selection and recruitment strategies, including risk analysis and mitigation

• Develop study budgets and align timelines with corporate objectives

• Oversight of monitoring activities and enforcement of site compliance

• Maintain standard work instructions and operating procedures, ensuring alignment with industry standards

• Responsible for reviewing and contributing to study documents (e.g. study protocols, clinical study reports, clinical report forms, reference guides).

• Oversight of clinical data management function

Travelling Requirement    Occasional travel to study centers, professional conferences, and Advanced Bionics corporate events

What you bring to the team:

Basic Education     Bachelor’s degree in a medically related discipline

Post-baccalaureate degree

Further Education 

Training in clinical trial management

Training in electronic data management

Work Experience   

Eight years of experience managing clinical trials

Experience with active implantable or Class 3 medical devices

Personal Competencies    Solution-oriented mindset

Open to continuous improvement

Social Competencies       

Exceptional spoken and written communication ability

Highly collaborative

Leadership Competencies

Three years of people leadership

Professional Competencies        Detailed understanding of clinical requirements for regulatory submission (FDA, ISO)         Experience with new product submission under MDR

Language(s) / Level        English fluency

IT skills       Expertise with standard MS Office software

Familiarity with electronic data systems

Our offer:

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

We love to work with great people and strongly believe that a diverse team makes us better.  We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted.  All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.