Real Staffing
Principal Regulatory Affairs Specialist
Real Staffing, Carlsbad, California, United States, 92002
One of our new cardiovascular client is looking to bring on a tenure Principal Regulatory Specialist to their team. This individual will be responsible for leading global regulatory strategy and execution for innovative medical device products. This role will be instrumental in driving successful market entry and ensuring compliance throughout the product life cycle. The ideal candidate will bring deep expertise in FDA, EMA, and EU MDR regulations, and thrive in a fast-paced, cross-functional environment.
Key Responsibilities
Lead regulatory strategy
for new product development and global market entry, including 510(k), PMA, and CE Mark submissions. Prepare, review, and manage
regulatory submissions to authorities such as the FDA, EMA, and other global agencies. Collaborate cross-functionally
with R&D, Quality, Clinical, and Marketing teams to align product development with regulatory requirements. Ensure regulatory compliance
throughout the product life cycle and proactively monitor changes in global regulations. Manage time lines and deliverables
across multiple regulatory projects to support successful product launches. Qualifications
Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree is a plus). Minimum of
6 years of regulatory experience
in the medical device industry with a proven track record of successful submissions. In-depth knowledge of
FDA, ISO, and EU MDR
regulatory frameworks. Hands-on experience with
510(k), PMA, and CE Marking
processes. Strong
project management, communication, and leadership
skills. Demonstrated experience in
mentoring and cross-functional collaboration . APPLY NOW FOR IMMEDIATE CONSIDERATION EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit the company website.
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Lead regulatory strategy
for new product development and global market entry, including 510(k), PMA, and CE Mark submissions. Prepare, review, and manage
regulatory submissions to authorities such as the FDA, EMA, and other global agencies. Collaborate cross-functionally
with R&D, Quality, Clinical, and Marketing teams to align product development with regulatory requirements. Ensure regulatory compliance
throughout the product life cycle and proactively monitor changes in global regulations. Manage time lines and deliverables
across multiple regulatory projects to support successful product launches. Qualifications
Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree is a plus). Minimum of
6 years of regulatory experience
in the medical device industry with a proven track record of successful submissions. In-depth knowledge of
FDA, ISO, and EU MDR
regulatory frameworks. Hands-on experience with
510(k), PMA, and CE Marking
processes. Strong
project management, communication, and leadership
skills. Demonstrated experience in
mentoring and cross-functional collaboration . APPLY NOW FOR IMMEDIATE CONSIDERATION EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit the company website.
#J-18808-Ljbffr