Senior Regulatory Quality Specialist Medical Devices (on-site)

AbbottMaple Grove, MN, US

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Senior Regulatory Quality Specialist

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.

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 - an affordable and convenient path to getting 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 that is 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.

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

We are looking for our next Senior Regulatory Quality Specialist to join our team on-site out of our Maple Grove, or St. Paul, MN locations. This Regulatory Quality Senior Specialist position would be structured under the Global Regulatory Services (GRS) function managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a RA QA Specialist is to combine the knowledge of Regulatory, Quality and Compliance to lead and assist implementation projects for emerging regulations and supporting quality compliance related activities for the GRS department. With limited supervision, coordinates and compiles regulatory procedures / processes and leads Regulatory systems projects to assure business needs are met and optimized for efficiency and effectiveness. Communicate with business partners to author and implement regulatory procedural changes. Support ongoing RA Operation system implementations and process improvements.

What You'll Work On

Lead procedural updates and emerging regulation implementation working with cross BU / cross functional teams

Develop new regulatory policies, processes and SOPs

Facilitate procedure implementation

Provide strategic input and technical guidance on regulatory requirements for process decisions

Evaluate regulatory risks of division policies, processes, procedures

Drive change order activities

Create supplemental training materials

Review and follow document quality system structure

Lead team meetings and document meeting minutes

Analyzes quality reports and metrics from tracking tools; identifies trends and ramifications

Work on process workflow development teams collaborating with Abbott IT system enhancement teams

Required Qualifications

Bachelor's degree or an equivalent combination of education and work experience

Minimum 3 years' experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development / support, scientific affairs, operations, or related area.

Experience with submission / registration types and requirements.

Write and edit technical documents.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

Master's Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.

5+ years' experience in a regulated industry

Knowledge of Regulations

Familiarity with Regulatory Affairs departmental responsibilities and processes

CAPA experience

Windchill experience

Procedural Writing

Regulatory Change Assessment

International Product Registration support

Ad and Promotional Material - Regulatory Review

EU and US medical device compliance

Project management skills organize and host meetings

Quality System maintenance activities

Documenting justification for change from Regulatory perspective

Regulatory history, guidelines, policies, standards, practices, requirements and precedents

GDP

Experience working in the Medical Device industry.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

The base pay for this position is $75,300.00 $150,700.00 In specific locations, the pay range may vary from the range posted.

Job Family : Regulatory Operations

Division : MD Medical Devices

Location : United States >

Maple Grove : 6820 Wedgwood Road N.

Additional Locations : United States >

Minnesota >

St. Paul >

Lillehei : One Lillehei Plaza

Work Shift : Standard

Travel : Yes, 5 % of the Time

Medical Surveillance : No

Significant Work Activities : Awkward / forceful / repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities / Women / Individuals with Disabilities / Protected Veterans. EEO is the Law link - English : http : / / webstorage.abbott.com / common / External / EEO_English.pdf EEO is the Law link - Espanol : http : / / webstorage.abbott.com / common / External / EEO_Spanish.pdf

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Senior Regulatory Specialist • Maple Grove, MN, US