Senior Manager, Regulatory Affairs

Job Description

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.

Senior Manager, Regulatory Affairs – St. Paul, MN

About Abbott

Leading an active lifestyle is important to the many people we serve. In Abbott’s ELECTROPHYSIOLOGY & HEART FAILURE division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives.

WHAT YOU’LL DO

We are recruiting for a Senior Manager, Regulatory Affairs to join our team in the St. Paul, MN location. In this role, you will be responsible for the regulatory and business issues to meet required legislation, enabling products to be developed, manufactured and distributed that can prolong life. You will be a key leader and influence at the department, group, and site levels and will be 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.

Responsibilities:

• 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 multi-country 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 related discipline
• 8+ years of experience in a similar position within a regulated industry (e.g., medical products, nutritionals, pharmaceutical), including general regulatory knowledge, guidelines, policies, standards, practices, requirements and precedents.
• Demonstrated experience leading functional groups in the development of relevant data to complete regulatory submissions
• Proficient in Microsoft Word, Excel, and PowerPoint
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Preferred

• Advanced level degree(s) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or related discipline
• Class III medical device experience.
• Certification, such as RAC from the Regulatory Affairs Professionals Society

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

Learn more about the benefits that add real value to your life to help you live fully: www.abbottbenefits.com

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.