Post Market Surveillance Manager - Medical Events Team
Location: United States - California - Alameda
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 the spectrum of healthcare, with leading businesses and products in 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 your 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.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
An excellent retirement savings plan with high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit—an affordable and convenient path to obtaining a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity:
The Post Market Surveillance Manager - Medical Events Team provides direct supervision and management to staff responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports globally for the division’s products. The manager is proficient with medical event reporting and complaint handling policies and procedures. Responsibilities include evaluating potentially reportable complaints in compliance with applicable regulations and ensuring that reportable events are filed with worldwide regulatory agencies in compliance with regulations. The manager also ensures that Abbott Diabetes Care (ADC) complaints are reviewed within established timeframes, escalates complaints requiring ADC Management and Medical Affairs guidance, and participates in discussions and decision-making processes to determine reportability.
What You'll Work On:
Responsible for scheduling day-to-day activities of the medical events group staff to ensure timely review of medical event files.
Ensures potentially reportable complaints are assessed against criteria for reportability and reports are filed as necessary in compliance with regulations.
Works closely with Customer Service, Complaint Handling, and Complaint Investigation teams to ensure the appropriate information is obtained from complainants to make accurate and timely assessments of reportability.
Establishes processes and procedures for medical event reporting within the framework of the complaint handling system.
Utilizes good judgment and makes timely decisions considering the facts and data at hand; champions specific projects; knows when to escalate to management.
Actively recruits, interviews, and participates in the hiring process of Medical Events Group members.
Participates as a team member and leader to monitor productivity, set priorities, and shift resources as appropriate to meet department goals.
Sets standards and monitors staff performance; establishes the motivational climate and productivity goals for the group; provides performance feedback; writes and conducts appraisals for employees.
Assists in the development of training and development plans.
Coordinates changing priorities and organizes process improvement projects.
Uses tools effectively to monitor progress and results.
Required Qualifications:
Education: Bachelor’s Degree or an equivalent combination of education and work experience.
Experience:
Minimum 5 years in the medical device field.
Minimum 3 years of management, supervisory, or team leadership experience required.
Knowledge & Skills:
Experience with Quality Systems Regulations (21CFR820) and Medical Device Reporting (21CFR803).
Familiarity with ISO standard 13485.
Experience with complaint handling (21CFR820.198).
Apply Now:
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits: 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 at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.
Compensation:
The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Boca Raton | Brooksville | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Portugal :
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Mexico |South Carolina :
Charleston |Tennessee :
Knoxville | Memphis | Nashville |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |United states :
fairmont | Georgia | OH | United States |United States :
Hawai | kentucky | Sylmar | Woonsocket |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |WI :
Madison | Wausau |Wisconsin :
Portage |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
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Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
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Remote Australia |Republic of Western Australia :
Nedlands |Cork :
Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Capital of Netherland :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |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 :
Richmond Hill | Mississauga | Uxbridge | Renfrew | North York |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |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 :
Yavne | Be'Er Sheva | Kfar Saba | Netanya | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
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Ciudad de México |North Island :
Auckland |Lima Region :
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Warsaw |Remote :
Remote - Europe | Remote, USA | Switzerland | Remote | Remote - Middle East | Remote - South America (Latin Americal) | Remote - Africa |Bucharest :
Bucharest |Makkah :
Jeddah | Khulais | Rabigh | Riyadh | King Abdullah Economic City | Najran |Nišava District :
Niš |Singapore :
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South Africa | Midrand |Brazil :
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Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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