Ormco Regulatory Affairs Specialist (Hybrid-Brea, CA)

Job Description:

JOB SUMMARY:

The Regulatory Affairs Specialist (RA Specialist) creates, evaluates and completes regulatory tasks related to the following: 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.

PRIMARY DUTIES & RESPONSIBILITIES:

• Regulatory professionals stay up to date with relevant regulations, including proposed and final rules issued by regulatory authorities. They understand how these regulations impact the company and thus must stay up to date and provide regulatory support as needed.
• Create procedures and standard operating procedures (SOPs) and technical documentation that link to regulatory operations. Clear documentation is essential for compliance.
• Assist in drafting Technical Files and accumulate technical documentation for global product registrations. They work closely with global registration teams to facilitate registrations for a large portfolio of products.
• Implement and coordinate regulatory strategies and plans from senior leadership. This involves ensuring timely product registrations in compliance with regulations and guidance.
• Prepare and maintain regulatory submissions, product registrations, certifications, and facility registrations. They follow country-specific requirements to facilitate product approvals in various regions.
• Work directly with distributors, in-country consultants, inter-company partners, and commercial partners to fulfill regulatory requirements for product registration.
• Review and assess product, manufacturing, and labeling changes for regulatory reporting impact and compliance.
• Be a strategic partner who can help navigate complex compliance landscapes and ensure timely product registrations worldwide.
• Follow Envista CIRCL values. Incorporate CIRCL values into daily work. Be customer centric and build ethical, supportive relationships with customers.

Job Requirements:

• Bachelor's Degree (BA/BS) from four-year college/university
• 3+ years of medical device experience, and/or training in an FDA-regulated industry, or equivalent combination of education and experience; or 2+ years regulatory experience with a master’s degree from a college/university.

PREFERRED QUALIFICATIONS:

• 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).

SKILLS/QUALIFICATIONS:

• Be respectful of peers. Open-minded and willing to take an educated risk, fail fast and try again.
• Ability to challenge the status quo and seek opportunities to set new standards.
• Ability to take accountability of his/her work, good or bad. Takes initiative to make a positive difference and win with our customers and co-workers.
• Maintains a sense of urgency and attention to detail. Must have “can do” attitude and be a team player.
• Proven ability to prioritize assigned projects and manage time effectively to meet all deadlines.
• Ability to be flexible and adaptable. Know when to ask questions. Have a positive attitude. Demonstrate a commitment to getting the job done right and on time.
• Be able to successfully manage multiple projects and product families.
• Must be comfortable dealing with ambiguity, relying on critical thinking to accomplish project goals
• Maintain a professional demeaner under pressure. Begin to demonstrate problem-solving skills and creativity. Ability to persuade coworkers in a positive, partnership perspective.
• Be able to see the big picture and how your projects fit into corporate goals and objectives.
• Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision.
• 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