Regulatory Associate

Location Type: On-site

Industry: Quality Assurance

Company: Breg

Are you looking for an exciting opportunity?

We currently have a full-time opening for a Regulatory Associate in our Carlsbad locationIf you are looking for a fast-paced environment where you can make a difference every day, then this is the opportunity for you!

The right person to join our team is…

Demonstrates ownership and accountability; Demonstrates the ability to: plan, execute, control and deliver; communicate effectively both written and verbal; lead and influence others effectively, demonstrates excellent judgement, comfort with escalating issues and requesting support when needed. Maintains high ethical standards and professionalism with the ability to handle confidential, private, and sensitive information effectively; preserves individual credibility; and positively collaborates with others. The ability to maintain a positive productive resourceful attitude, multitask, prioritize, and meet deadlines in a fast-paced environment, ability to build and maintain positive relationships with diverse stakeholders.

This position is responsible for….

The Regulatory Associate assists with domestic and international regulatory submissions and product registrations. This position is also responsible for ensuring regulatory compliance for market-released products and organizational initiatives.

Your day will be very busy… 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.

What your background will be:

• 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.

What we can offer you…

Our insurance benefits are effective the 1st of the month after your hire date.

• Medical/Dental/Vision/Disability plans
• Paid time off (PTO)
• Company paid Holiday Pay
• Company paid Basic Life Insurance

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

Salary/Pay Range:

$32.00 – $37.00 per hour

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.

For six consecutive years Breg was awarded The National Business Research Institute (NBRI) Circle of Excellence Award for employee engagement.

If you meet the requirements above and would like to apply for this position, please visit our website at www.breg.com and click on the ‘Careers’ section.

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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