Regulatory Associate

Join Our Team and Keep Moving Forward with Breg!

At Breg, we are dedicated to advancing orthopedic solutions that enhance the lives of patients and support healthcare professionals. As a leader in the orthopedic industry, we provide innovative products, consulting, technology, and services that help people move forward with confidence.

We are currently seeking a Regulatory Associate to join our team in Carlsbad, CA. If you thrive in a dynamic environment where innovation and impact go hand in hand, this is the opportunity for you.

Who You Are

You are a forward-thinking professional who values collaboration, innovation, and making a meaningful difference. You bring expertise in ownership and accountability, collaborating with others, multitasking, prioritizing, maintaining positive relationships with diverse stakeholders and are eager to contribute to a team that is committed to delivering exceptional patient outcomes.

What You'll Do

As a Regulatory Associate, you will:

• Coordinates and assembles documentation to support regulatory submissions and product registrations domestic and international to obtain device marketing authorization.

• Monitors, tracks, and coordinates regulatory requests and correspondence.

• Maintains regulatory files, including FDA 510(k) submissions, Canadian MDL (Medical Device License) documentation, Japanese marketing approvals, Australian documentation, EU/UK technical documentation and product licensing and updates and maintains regulatory information in Product Lifecycle Management System.

• Updates and maintains external regulatory databases: EUDAMED (European Database on Medical Devices), GUDID (Global Unique Device Identification Database), etc.

• Supports the elevated complaint process to ensure compliance to domestic and international reporting requirements.

• Manages external standards, directives, regulations to ensure latest revisions and oversees impact assessments, including implementation of procedural and documentation updates when necessary.

• Assists with ongoing post market surveillance evaluation, trending, and reporting.

• Creates and maintains product specification sheets.

• Keeps updated on regulatory changes and updates procedures as required and supports organizations cross-functional initiatives for regulatory activities,

• Develops and revises corporate procedures to ensure compliance with applicable global regulatory requirements.

• Provides department support during internal and external audits including readiness activities.

• Ensures regulatory compliance with established company and departmental policies and procedures, objectives, quality systems, regulations, safety, and environmental standards.

• Supports in financial transactions between Breg and international entities.

• Responsible for behaving in a professional manner both internally and externally in relationships that positively impact the company's reputation and comply with the company's policies and practices. Responsible for being accountable and committed to demonstrating Breg's cultural beliefs and achieving the key results of the company.

• Responsible for promoting Breg's culture within the organization using established tools such as storytelling, providing focused feedback, and recognition. The performance of the position is aligned with the culture of commitment and accountability, following the steps of: See it, Own it, Solve it, and Do it.

• Collaborate with cross-functional teams to drive excellence in patient care and business solutions.

What You Bring

• Bachelor's degree in a science or engineering related field is preferred.
• 1+ years of experience in the medical device industry or other scientific industry is preferred.
• Knowledge of MDSAP (Medical Device Single Audit Program) requirements for the United States, Canada, Australia, Brazil and Japan FDA (Food and Drug Administration) QSR (Quality System Requirements) ISO (International Organization for Standardization) 13485:2016, EU MDR (European Union Medical Device Regulation) 2017/745, and UK MDR (UK Medical Device Regulation) 2002 is required
• 1+ years of experience supporting FDA (Federal Drug Administration), Competent Authority, and Notified/Approved Body audits and requests is required.
• Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, Teams, and Power Point capabilities. Technical competence includes the ability to learn new software and systems. Basic database knowledge is required.
• A passion for innovation and a commitment to Breg's mission to Keep Moving Forward.

Why Breg?

At Breg, we invest in our people and culture. We offer:

• Comprehensive Benefits: Medical, dental, vision, disability, and life insurance, effective the first of the month after hire.
• Work-Life Balance: Paid Time Off (PTO) and company-paid holidays.
• Growth & Development: Opportunities for professional advancement within a company that values your contributions.
• Commitment to Diversity & Inclusion: Breg is proud to be an Equal Employment Opportunity employer, fostering a diverse and inclusive workplace.

• For more information regarding Company benefits, please see https://www.breg.com/benefits

Compensation

Salary Range: $32.00 - $37.00 hourly. Actual compensation is determined by factors such as experience, skills, and business needs. This range reflects the minimum and maximum target range for new hire base salary/pay across all US locations. Actual pay is based on many factors unique to each candidate, including but not limited to geographical location, work experience, skill set, relevant trainings and certifications, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for a bonus.

Ready to Move Forward?

If you're ready to be part of a company that is redefining orthopedic care, apply today at www.breg.com/careers.

Breg is an Equal Employment Opportunity Employer and dedicated to a diverse work force and Drug Free work environment. EOE/Minorities/Females/Vet/Disabled are encouraged to apply.

Applicants must be currently authorized to work in the United States on a full-time basis. The Company will not sponsor applicants for work visas for this position.

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