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Manager Regulatory Affairs

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 109,000 colleagues serve people in more than 160 countries.

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

**WHAT YOU'LL DO:**

As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may analyze broad scope implications of changing regulations and guidance. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.

+ Develop new regulatory policies, processes and SOPs and train key personnel on them. Evaluate regulatory risks of, division policies, processes, procedures. Recruit, develop and manage regulatory professionals.

+ Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and technical guidance on regulatory requirements to development teams.

+ Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes.

+ Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.

+ Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Monitor trade association positions for impact on company products.

+ Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.

+ Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.

+ Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.

+ Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

+ Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

+ Manage and execute preapproval compliance activities Postmarket. Oversee processes involved with maintaining annual licenses, registrations, listings and patent information. Ensure compliance with product postmarketing approval requirements. May assist in review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations.

+ Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Analyze product-associated problems and develop proposals for solutions.

+ Provide regulatory input for product associated events and reports to regulatory bodies, product recalls and recall communications.

+ Individuals execute and manage technical and scientific regulatory activities. Must function independently as a decision-maker on regulatory issues, and must assure that deadlines are met.

+ Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.

+ Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments. Completed work is reviewed from a relatively long- term perspective for desired results. Individual is recognized as a discipline expert and resource in regulatory affairs.

Influence/Leadership:

+ Develops, communicates, and builds consensus for operating goals that are in alignment with the division.

+ Provides leadership by communicating and providing guidance towards achieving department objectives.

+ Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.

+ May lead a cross-functional or cross-divisional project team.

+ Provides technical leadership to business units.

+ Acts as a mentor to less-experienced staff.

+ Exercises judgment independently.

Planning/Organization:

+ Creates immediate to long-range plans to carry out objectives established by top management.

+ Develops and calculates a budget for a department or group to meet organizational goals.

+ Forecasts future needs including human and material resources and capital expenditures.

+ Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.

Decision Making/Impact:

+ Assignments are expressed in the form of objectives

+ Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.

+ Individual understands the consequences of erroneous decisions or recommendations which could result in critical delays and modifications to projects or operations with substantial expenditure of time, human resources, and funds, and may jeopardize future business activity.

**EDUCATION & EXPERIENCE YOU'LL BRING:**

+ Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical field is preferred).

+ Master's degree in technical area or MBA is preferred

+ PhD in technical area or law is helpful

+ Minimum of 4-5 years experience in a regulated industry (preferably in medical devices). 2-5 years of experience directly in regulatory affairs strongly preferred (but may consider quality assurance, research and development/support, scientific affairs, operations, or related area).

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

+ Regulatory Knowledge of (as applicable): · Regulatory history, guidelines, policies, standards, practices, requirements and precedents · Experience writing/submitting and reviewing PMA, 510k, IDE applications, EU dossiers/Technical files and International submission files. Regulatory agency structure, processes and key personnel · Principles and requirements of applicable product laws · Submission/registration types and requirements · GxPs (GCPs, GLPs, GMPs) · Principles and requirements of promotion, advertising and labeling · International treaties and regional, national, local and territorial trade requirements, agreements and considerations · Domestic and international regulatory guidelines, policies and regulations · Ethical guidelines of the regulatory profession, clinical research and regulatory process · Lead functional groups in the development of relevant data to complete a regulatory submission.

+ Communication Skills or Ability to: · Communicate effectively verbally and in writing · Communicate with diverse audiences and personnel · Write and edit technical documents · Work with cross-functional teams · Work with people from various disciplines and cultures · Write and edit technical documents · Negotiate internally and externally with regulatory agencies · Plan and conduct meetings.

+ Cognitive Skills or Ability to: · Strong attention to detail · Manage projects · Create project plans and timelines · Must be able to juggle multiple and competing priorities · Think analytically with good problem solving skills · Organize and track complex information · Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results · Has broad knowledge of various technical alternatives and their potential impact on the business · Exercises good and ethical judgment within policy and regulations · Uses in-depth knowledge of business functions and cross group dependencies/ relationships · Possesses ability to define regulatory strategy · Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues · Perform risk assessment or analysis

**WHAT WE OFFER:**

At Abbott, you can have a good job that can grow into a great career. We offer:

+ **Training and career development** , with onboarding programs for new employees and tuition assistance

+ **Financial security** through competitive compensation, incentives and retirement plans

+ **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs

+ **Paid time off**

+ **401(k)** retirement savings with a generous company match

+ **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities

**Learn more about our benefits that add real value to your life to help you live fully: ** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Manager Regulatory Affairs

Full time
Plymouth, MN

Published on 04/17/2021

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