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|Title:||Sr. Clinical Affairs Specialist|
|Job Location:||Carlsbad, California - United States|
|Salary:||$100,000.00 - $110,000.00 - US Dollars - Yearly|
|Other Compensation:||Bonus, Benefits, Profit Sharing|
|Employer Will Recruit From:||Nationwide|
Our client is one of the most stable dental establishments in San Diego County. Founded over 40 years ago, they have grown to become a global leader in the design, development, and distribution of diversified dental solutions. This is an ideal company for our candidates that want to enter the dental industry without being limited to the status quo, as our client is always looking to deliver quality patient care with unique, innovative techniques. They are seeking an experienced Senior Clinical Affairs Specialist to add to their growing, highly stable team.
This is a direct hire opportunity based in Carlsbad, CA. This position offers excellent benefits, bonus, and profit sharing.
· Authoring Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4.
· Authoring Post Market Clinical Follow-up Reports in accordance with MEDDEV 2.12/2 rev 2.
· Conducting Post Market Surveillance, including protocols and reports, in accordance with EU requirements.
· Assist the Regulatory Affairs Director and Manager with Clinical activities to ensure compliance with the new European Medical Device Regulations (MDR).
· Ensure compliance with US and international regulations and guidelines.
· Other duties as assigned.
• Bachelor’s Degree in biology, chemistry, biochemistry, microbiology, or related discipline 5 years of professional experience or minimum 10 years documented professional experience without a degree.
• Experience in the dental field with knowledge of the devices subject to evaluation is highly desired.
• Must have knowledge in medical writing and research methodology, including clinical investigation design and biostatistics.
• Experience authoring Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4; authoring Post Market Clinical Follow-up Reports, in accordance with MEDDEV 2.12/2 rev 2; conducting Post Market Surveillance, including protocols and reports, in accordance with EU requirements.
• Must be knowledgeable in MDR requirements.
• Experience with the use of spreadsheets, word-processing, and database application software (i.e. Excel, Adobe, Word).
• Flexibility and agility to accommodate constant project changes and time constraints.
• Ability to work in collaborative and independent work situations with minimal supervision.
• Demonstrated interest and capability in learning subject matter and processes.
• Demonstrated ability to solve problems with limited or no supervision.
• Demonstrated effective interpersonal, teamwork, and communication skills required.
• Ability to use Regulatory information systems.
Applicants must be authorized to work for any U.S. employer. Sponsorship is not available for this position.
Staff Smart, Inc. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Some relocation assistance is available for this role.
University - Bachelor's Degree/3-4 Year Degree