Real Staffing
Staff Regulatory Affairs Specialist
Real Staffing, Aliso Viejo, California, United States, 92656
Our client, a leading innovator in class II/III implantable medical technologies, is seeking a
Staff Principal Regulatory Affairs
professional to lead global product approval strategies. This role is instrumental in ensuring regulatory compliance and successful market access across the US, EU, and Canada.
About the Company Our client is a global medical device organization known for its cutting‑edge technologies and commitment to improving patient outcomes. With a strong focus on research and development, they deliver life‑saving solutions that address some of the most complex vascular conditions. The company fosters a collaborative, high‑performance culture and offers opportunities for professional growth and cross‑functional leadership.
Role Overview This position will lead the development and execution of regulatory strategies for class II/III implantable devices, ensuring alignment with global business objectives and compliance with FDA and international regulatory requirements.
Key Responsibilities
Develop and implement global regulatory strategies for assigned markets.
Represent Regulatory Affairs on cross‑functional teams to ensure strategic alignment.
Prepare, review, and submit regulatory filings (FDA, CE Mark, Health Canada, ROW).
Communicate with regulatory agencies and maintain thorough documentation.
Assess regulatory impact of product changes and review promotional materials for compliance.
Maintain regulatory documentation and contribute to SOP and work instruction updates.
Mentor team members and support global regulatory training initiatives.
Ensure compliance with applicable laws, regulations, and internal quality systems.
Required Qualifications
Bachelor's degree in a scientific or technical discipline.
Minimum of 5 years of regulatory experience in the medical device industry.
Proven success with FDA Class II/III submissions, CE Mark applications, and Health Canada filings.
Experience communicating directly with regulatory authorities.
Strong technical writing and verbal communication skills.
Proficiency in Microsoft Office tools (Word, Excel, Outlook, Teams).
Preferred Qualifications
Advanced degree in a relevant scientific or technical field.
Experience leading medium to large teams.
Strong analytical and organizational skills.
Ability to interpret complex technical documentation.
This is a unique opportunity to join a mission‑driven organization at the forefront of medical innovation. If you're ready to make a global impact and help bring transformative technologies to market, we encourage you to apply.
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.
#J-18808-Ljbffr
Staff Principal Regulatory Affairs
professional to lead global product approval strategies. This role is instrumental in ensuring regulatory compliance and successful market access across the US, EU, and Canada.
About the Company Our client is a global medical device organization known for its cutting‑edge technologies and commitment to improving patient outcomes. With a strong focus on research and development, they deliver life‑saving solutions that address some of the most complex vascular conditions. The company fosters a collaborative, high‑performance culture and offers opportunities for professional growth and cross‑functional leadership.
Role Overview This position will lead the development and execution of regulatory strategies for class II/III implantable devices, ensuring alignment with global business objectives and compliance with FDA and international regulatory requirements.
Key Responsibilities
Develop and implement global regulatory strategies for assigned markets.
Represent Regulatory Affairs on cross‑functional teams to ensure strategic alignment.
Prepare, review, and submit regulatory filings (FDA, CE Mark, Health Canada, ROW).
Communicate with regulatory agencies and maintain thorough documentation.
Assess regulatory impact of product changes and review promotional materials for compliance.
Maintain regulatory documentation and contribute to SOP and work instruction updates.
Mentor team members and support global regulatory training initiatives.
Ensure compliance with applicable laws, regulations, and internal quality systems.
Required Qualifications
Bachelor's degree in a scientific or technical discipline.
Minimum of 5 years of regulatory experience in the medical device industry.
Proven success with FDA Class II/III submissions, CE Mark applications, and Health Canada filings.
Experience communicating directly with regulatory authorities.
Strong technical writing and verbal communication skills.
Proficiency in Microsoft Office tools (Word, Excel, Outlook, Teams).
Preferred Qualifications
Advanced degree in a relevant scientific or technical field.
Experience leading medium to large teams.
Strong analytical and organizational skills.
Ability to interpret complex technical documentation.
This is a unique opportunity to join a mission‑driven organization at the forefront of medical innovation. If you're ready to make a global impact and help bring transformative technologies to market, we encourage you to apply.
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.
#J-18808-Ljbffr