Regulatory Affairs Specialist Ii – Cardiac Rhythm Management (On-Site)

2+ years

$79,500.00 – $138,700.00

Sylmar

10 March 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Specialist II – Cardiac Rhythm Management (On-Site)
Location: United States - California - Sylmar
Category: Regulatory Affairs

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott
At Abbott, you can do work that matters, grow and learn, care for yourself and family, be your true self, and live a full life. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
A company recognized as a great place to work in dozens of countries and named one of the most admired companies in the world by Fortune.
Recognition as one of the best big companies to work for and a best place to work for diversity, working mothers, female executives, and scientists.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

The Opportunity
We are hiring a Regulatory Affairs Specialist II to work on-site at our Cardiac Rhythm Management (CRM) location in Sylmar, CA. This new hire will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, this specialist will support necessary regulatory activities required for product market entry.

What You’ll Work On:

Liaison with global affiliates to create robust regulatory applications (for international regulatory agencies) to achieve departmental and organizational objectives.
Review, assess, and approve engineering changes.
Act as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
Review and evaluate communications to ensure all necessary details are conveyed and adhere to applicable regulatory standards, including those set by the FDA or other worldwide regulatory agencies.
Keep current on pertinent domestic and international medical device regulations to ensure submission requirements worldwide are up-to-date.
Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
Review protocols and reports to support regulatory submissions.
Support all business segment initiatives as identified by divisional management in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications:

Bachelor's degree or an equivalent combination of education and work experience.
Minimum 2 years of experience in a regulated industry (e.g., medical products, nutritionals). Regulatory experience preferred but may consider quality assurance, R&D, scientific affairs, operations, or related areas.
Experience with submission/registration types and requirements.
Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization.
Ability to multitask, prioritize, and meet deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications:

Bachelor's degree in science/technical discipline (engineering, life sciences, mathematics); Master’s degree preferred.
Experience with 510(k) applications, PMA supplements, US device regulations, EU, and other international medical device regulations and submissions.
Working knowledge of Arabic, Persian, Turkish, or Russian languages.
Prior Middle East, Africa, or Eastern European regulatory experience.
MDSAP or similar audit support experience.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Experience working in a broader enterprise/cross-division business unit model.
Experience working in the Medical Device industry.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us:

Website: www.abbott.com
Facebook: www.facebook.com/Abbott
Twitter: @AbbottNews and @AbbottGlobal

Salary Range:
The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.

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Regulatory Affairs Specialist Ii – Cardiac Rhythm Management (On-Site)

Job Description

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