Regulatory Affairs Specialist

Envista Holdings Corporation•Brea, CA

2d•$85,800 - $104,800•Onsite

About The Position

The Regulatory Affairs Specialist (RA) creates, evaluates and completes regulatory tasks related to worldwide product registration submissions, facility registrations, special projects and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory registrations/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. This position is required to be on-site at least four days a week.

Requirements

Bachelor's Degree
2+ years of Regulatory Affairs experience in medical devices or other regulated industry.
Master’s Degree with 1+ years of Regulatory Affairs experience in medical devices or other regulated industry.
Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated experience with Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Post-Market Surveillance (PMS), and Periodic Safety Update Reports (PSUR).
Demonstrated organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite, databases and electronic document management systems.
Enthusiastic self-starter with excellent verbal, written, and interpersonal skills.
Highly organized, detail-oriented “mindset” and ability to be flexible and multi-task in a dynamically changing environment.
The ability to interpret and provide guidance on regulations from various countries.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.

Nice To Haves

Advanced degree or RAC certification preferred.
Master's in Regulatory Science preferred.
Demonstrated international submissions experience (i.e., APAC, LATAM, Australia TGA, Health Canada, and/or EU Technical files a plus).

Responsibilities

Assemble and maintain CE technical files in accordance with applicable regulatory requirements.
Author, review, and approve Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and Post-Market Surveillance (PMS) reports.
Monitor and interpret regulatory changes, including proposed and final rules issued by global regulatory authorities, and assess their impact on company operations.
Develop and maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations.
Collaborate with global registration teams to support product registrations across a diverse portfolio, ensuring alignment with country-specific requirements.
Implement and coordinate regulatory strategies and plans as directed by senior leadership, ensuring timely and compliant product registrations.
Prepare, submit, and maintain regulatory submissions, product registrations, certifications, and facility registrations for global markets.
Liaise with distributors, in-country consultants, inter-company partners, and commercial teams to fulfill regulatory requirements for product registration and compliance.
Review and evaluate product, manufacturing, and labeling changes to determine regulatory reporting obligations and ensure continued compliance.
Serve as a strategic regulatory partner, providing guidance on complex compliance landscapes and facilitating global product approvals.
Uphold and integrate Envista CIRCLe values into daily work, fostering customer-centric and ethical relationships with internal and external stakeholders.
Stay informed of new regulatory developments by reviewing relevant publications and industry updates.
Perform special projects and assignments as directed by Manager.