Regulatory Affairs Specialist II - United States
|Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. Always focused on innovations that improve quality of life, AB has consistently made the industry’s leading advancements in hearing technology. In fact, with six sound coding programs, we offer more ways to hear than any other cochlear implant company. |
Our company is part of the Sonova Group, the leading provider of hearing healthcare solutions and parent company of Phonak, the leading hearing instrument brand.
As an AB employee, you will contribute to advancing biomedical technology worldwide and work on challenging projects with smart, driven, friendly people.
AB provides thriving work environments around the globe; each fosters creativity, teamwork, global competitiveness, and professional growth.
Experience the professional and personal fulfillment that comes with making a difference in people’s lives. Apply to Advanced Bionics today.
|Advanced Bionics / USA / Valencia (CA)|
|Regulatory Affairs Specialist II|
| TASKS & RESPONSIBILITIES: |
Generate submissions (i.e. PMA, PMA supplements, CE marking applications, product registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Produce subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals.
In conjunction with Clinical Research, prepare applications (i.e. IDE) for conducting clinical investigations in U.S., Canada and EU countries. Generate required submissions (progress reports, etc.) to support the continuation of clinical studies.
Submit reports and information required by the complaint reporting and postmarket vigilance systems.
Provide input to engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development process and design/manufacture of the products.
Participate in the engineering change order process, by reviewing engineering and manufacturing document release and changes.
Review and provide input to labeling and marketing programs in reference to regulatory requirements.
Keep abreast of new or developments in various regulations and advise Regulatory Affairs management as necessary.
Participate in the Safety Review Board process.
Participate in the Patient Management Review Board process.
Participate as the lead for the Complaint Handling Group.
Other duties as assigned.
SPECIALIZED SKILLS & KNOWLEDGE:
Proficiency with MS Outlook, Word, Excel, PowerPoint, Access and SQL.
Good working knowledge of U.S. FDA, Canada and EU regulations and standards.
Excellent interpersonal, communication and negotiating skills.
RA certification (by Regulatory Affairs Professional Society) is a plus.
| EDUCATION & EXPERIENCE: |
Required a bachelor’s degree, preferably in scientific discipline or engineering.
Required 2 - 3 years of experience in the area of worldwide regulatory affairs (both submissions and compliance) at medical device companies, preferably under the Class III medical device environment.
Advanced Bionics is committed to creating a diverse environment and is proud to be an affirmative action/ equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
|Advanced Bionics is committed to creating a diverse environment and is proud to be an affirmative action/ equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.|
|Advanced Bionics LLC |
28515 Westinghouse Place
Valencia, CA 91355
+1 661 362 4747