Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you!
Working with some of the US’ premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We even go the extra mile with our signature Consultant Appreciation Program (CAP) to help them in their future job searches.
Hired by Matrix has provided talent solutions to enhance organizations’ team capacities for over three decades. As a full-service search firm, we partner with companies across industries, including Financial Services, Fintech, Consumer Goods and Services, Security and Logistics, Pharmaceutical / Biotech, Technology, Automotive, Engineering, and Healthcare.
At-a-Glance:
Are you ready to build your career by joining a multi-national medtech company? If so, our client is hiring a Sr. Regulatory Affairs Specialist!
What You’ll Do:

• Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements.
• Identifies, analyzes and implements country specific requirements necessary for product related submissions.
• Recommend strategies for earliest possible approvals for marketing applications.
• Performs regulatory projects or acts as a member of the project steering group.
• Submits required documentation/information to local authorities.
• Initiates and escalates necessary activities if deviations are identified.
• Ensures creation of adequate documentation for audits/inspections.
• Performs training within the organization in country specific regulatory requirements, if applicable.
• Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.
• Performs review of promotional material for regulatory compliance according to country specific requirements.

 What You Bring:

• 5 to 8 years’ experience.
• Product Registration Experience:

• Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files.
• Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
• Knowledge of regulatory guidance documents (FDA, Health Canada, and EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
• Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1 as evidenced by coursework or submissions that required use of each standard.

• Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.
• Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

 Position Type: Contract
Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Rishaw at 646-688-5839 to learn more.
Who We Are:
Since 1986, Hired by Matrix, Inc. has improved our candidates' lives with exciting job opportunities that provide outstanding career advancement. Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days, and a 401k option with a company match after one year. Hired by Matrix is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business.
Connect with us on LinkedIn today and learn more about how HbM can change your career: https://www.linkedin.com/company/hired-by-matrix-inc/
Check out our Career Center: https://www.hiredbymatrix.com/find-work/open-positions/
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About the Company:
Hired by Matrix

We believe in putting people together for the right reasons. Getting you a great job that makes you feel fulfilled in your career. Finding the perfect candidate to help you achieve business success.Whether you are looking for the best candidate for your company or searching for your next career move, we are dedicated to making sure you thrive. We take your needs personally and have a variety of services to ensure you reach your goals. We listen to the needs of our clients and candidates and then thoughtfully match the right person with the right job. When people come together doing what they love success is guaranteed and partnerships last.

Company Size:
100 to 499 employees

Industry:
Staffing/Employment Agencies

Founded:
0

Website:
http://www.hiredbymatrix.com