Senior Regulatory Affairs Specialist2 – Cardiac Rhythm Management (On-Site)

3+ years

$86,700.00 – $173,300.00

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

Senior 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. With 114,000 colleagues in more than 160 countries, Abbott is committed to innovation and excellence.

Working at Abbott:

At Abbott, you will:

Grow your career with an international company.
Qualify for free medical coverage through our Health Investment Plan (HIP) PPO.
Benefit from an excellent retirement savings plan with high employer contributions.
Access tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefits.
Work for a company recognized globally for workplace excellence and diversity.

As a global leader in Cardiac Rhythm Technologies, Abbott focuses on innovative solutions that enhance the treatment of heart arrhythmias and irregular heartbeats.

The Opportunity:

Abbott’s Cardiac Rhythm Management division in Sylmar, CA has an on-site opportunity for a Senior Regulatory Affairs Specialist. This position leads the preparation and submission of regulatory approvals, acts independently to identify and resolve problems, and provides regulatory guidance to cross-functional partners. This role requires strategic thinking and creativity to support regulatory programs.

Responsibilities:

Prepare regulatory applications to achieve departmental and organizational objectives.
Create, review, and approve change orders.
Serve as a regulatory representative on core product development teams, communicating regulatory requirements and their impact.
Act as a liaison between Abbott and regulatory agencies, ensuring effective communication.
Maintain ongoing surveillance and analysis of global medical device regulations to ensure compliance.
Review device labeling and marketing materials for regulatory compliance.
Interface directly with FDA and other regulatory agencies.
Support the product release process by managing GTS licenses and approvals.
Conduct product and manufacturing change reviews for regulatory compliance.
Review protocols and reports to support regulatory submissions.
Ensure compliance with FDA, international regulations, and company policies.
Maintain collaborative communications with employees, customers, contractors, and vendors.
Provide mentorship and leadership to Regulatory Specialist I and II team members.

Required Qualifications:

Bachelor's degree or an equivalent combination of education and work experience.
Minimum 3 years of experience in a regulated industry (e.g., medical devices, nutritionals).
2-3 years of regulatory experience preferred (may consider quality assurance, R&D, scientific affairs, or related fields).
Experience with submission/registration types and requirements.
Strong verbal and written communication skills for multiple levels of an organization.
Ability to multitask, prioritize, and meet deadlines.
Strong organizational and follow-up skills with attention to detail.

Preferred Qualifications:

Master’s degree in Regulatory Affairs (may substitute for direct regulatory experience).
Experience with 510(k) applications, PMA supplements, and US device regulations or EU and other international medical device regulations.
Ability to work in a matrixed and diverse business environment.
Experience in the Medical Device industry.
Regulatory Affairs Certification (RAC) is a plus.

Compensation:

Base Pay: $86,700 – $173,300 (may vary by location).

Apply Now:

Learn more about Abbott’s health and wellness benefits at www.abbottbenefits.com.

Abbott is an Equal Opportunity Employer committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Knoxville | Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in England

North Yorkshire :

Harrogate |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Lyon | Paris |

Attica :

Koropi | Athens |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Brazil | Sao paulo |

South America :

Argentina | Peru |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Senior Regulatory Affairs Specialist2 – Cardiac Rhythm Management (On-Site)

Job Description

About Abbott:

Working at Abbott:

The Opportunity:

Responsibilities:

Required Qualifications:

Preferred Qualifications:

Compensation:

Apply Now:

Latest Jobs

Senior Cra

Quality Control Lab Technician

Associate Dean Of Clinical Affairs - Hs Associate / Full Clinical Professor

Associate Director, Global Pv Operations - Job Id: Gpv

Representative, Operations

Clinical Data Manager

Global Leader - Mlr Services

Lead - Business Analyst

Associate Manager - Regulatory Solutions

Lead - Regulatory Solutions