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Regulatory Affairs Manager – CardioMEMS

Abbott Laboratories

This is a Full-time position in Atlanta, GA posted November 8, 2021.

This job is available in 6 locations Category 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.

About EPHF

Leading an active lifestyle is vitally important to the people we serve.

In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

Due to growth, we are currently adding a Manager of Regulatory Affairs to our Atlanta, GA team.

WHAT YOU’LL DO  

As Manager of Regulatory Affairs, you will leverage your knowledge of scientific, regulatory and business issues to meet required legislation, enabling products to be developed, manufactured and distributed that can prolong life.

This key leader has influence at the department, group and site levels and is the recognized expert and resource within the department and may be tasked to analyze broad scope implications of changing regulations and guidance.

You will identify data requirements, obtain data and ensure information is presented effectively for the successful registration of products worldwide.

Your accountabilities and opportunities in this role:

  • Develop new regulatory policies, processes and SOPs and train key personnel. 
  • Evaluate regulatory risks of division policies, processes, procedures.
  • Recruit, develop and manage team of 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 and assist in regulatory due diligence for potential and new acquisitions.
  • Propose strategies on complex issues.

    Determine submission and approval requirements.

  • Identify emerging issues and anticipate regulatory obstacles throughout the product lifecycle.

    Develop solutions in collaboration with 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 appropriate responses 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 successful submission approval.
  • Manage preapproval compliance activities post-market.

    Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.

    Ensure compliance with product post-marketing approval requirements

  • 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.

  • Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.

    Report adverse events to regulatory agencies and internal stakeholders.

    Provide regulatory input for product recalls and recall communications.

  • Execute and manage technical and scientific regulatory activities independently as a decision-maker on regulatory issues, and 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 with limited direction and exercise some latitude in determining technical objectives of assignments.

    Completed work is reviewed from a relatively long-term perspective for desired results.

EDUCATION AND EXPERIENCE YOU’LL BRING  

Required  

  • Bachelors Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred or an equivalent combination of education and work experience.
  • 8-10 + years experience in a regulated industry (e.g., medical products, nutritionals).
  • Regulatory Knowledge including Regulatory history, guidelines, policies, standards, practices, requirements and precedents.

    Solid understanding of regulatory agency structure, processes and key personnel, principles and requirements of applicable product laws and s ubmission/registration types and requirements.

    GxPs (GCPs, GLPs, GMPs) experience.

    Knowledge of principles and requirements of promotion, advertising and labeling.

  • Knowledge of international treaties and regional, national, local and territorial trade requirements, agreements and considerations.
  • Domestic and international regulatory guidelines, policies and regulations experience.
  • Ethical guidelines of the regulatory profession, clinical research and regulatory process.
  • Experience leading functional groups in the development of relevant data to complete regulatory submissions.

Preferred  

  • 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • M.S.

    in a technical area or M.B.A.

    is preferred.

  • Ph.D.

    in a technical area or law is helpful.

  • Certification, such as RAC from the Regulatory Affairs Professionals Society, is a plus.
  • Influence/Leadership: Interface cross-functionally and at all levels across the organization; provide technical leadership to business units; mentor junior employees; exercise judgment independently.
  • Planning/Organization: Immediate to long range planning; budget management; forecasting future needs including human and material resources and capital expenditures
  • Decision Making/Impact: Effective decision-making is critical to this important role.

WHAT 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
  • Generous, paid time off
  • 401(k) retirement savings with a generous company match
  • Stability of a company with a record of strong financial performance and history of being actively involved in local communities

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.

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures…

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures…

Location United States
– Georgia
– Atlanta Category Operations

For years, Abbott’s MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive.

Whether it’s glucose monitoring systems, innovative therapies for treating heart…

Job Id 30979964 Medical surveillance No Division EPHF Electrophysiology & Heart Failure Travel Yes, 10 % of the Time Additional Location United States
– Georgia
– Alpharetta,United States
– Georgia
– Columbus,United States
– Georgia
– Athens,United States
– Georgia
– Decatur,United States
– Georgia
– Macon Significant work activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)

PLAN FOR SUCCESS

CAREER OPPORTUNITIES

Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.

GROWTH PLANNING

Growth Planning and Performance Excellence is an annual process through which you’ll be able to have open career discussions with your manager to help you determine your own career path and future.

TRAINING & NETWORKS

We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.

WE’RE RECOGNIZED AROUND THE WORLD

DOW JONES SUSTAINABILITY INDEX

BEST CORPORATE CITIZENS

FORTUNE CHANGE
THE WORLD

FORTUNE’S MOST ADMIRED COMPANIES

JOIN OUR TALENT COMMUNITY

We will notify you about relevant positions, and keep you in mind when we have interesting opportunities.

Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans.

We provide reasonable accommodation to qualified individuals with disabilities.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.

No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.


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