Regulatory Affairs Job at Abbott | Apply Now
Regulatory affairs job opportunities are growing rapidly in the healthcare sector, and this role at Abbott offers an excellent chance to build a rewarding career. As a global leader in healthcare, Abbott provides innovative solutions across diagnostics, medical devices, nutrition, and pharmaceuticals, making it one of the most sought-after abbott careers for professionals exploring life science jobs in US.
- Job Position: Regulatory Affairs Specialist I – Electrophysiology (on-site)
- Location: United States – Minnesota – Plymouth
About the Company
Regulatory affairs job seekers looking for impactful roles will find Abbott to be a leading global healthcare company that helps people live more fully at all stages of life. Its portfolio includes life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. With 115,000 employees serving in over 160 countries, Abbott continues to be a top choice for abbott careers and life science jobs in US.
Job Description
Regulatory affairs job role at Abbott involves performing specialized work assignments including analysis, evaluation, preparation, and submission of regulatory documentation. The position ensures that products and procedures comply with regulatory agency specifications and supports regulatory activities required for product market entry. This role is ideal for candidates seeking abbott careers in life science jobs in US within the electrophysiology domain.
Qualifications
Required
Regulatory affairs job requirements include:
- Bachelor’s Degree or an equivalent combination of education and work experience
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Strong organizational and follow-up skills, attention to detail and focus towards improving quality
- Ability to multitask, prioritize and meet deadlines in timely manner
Preferred
Regulatory affairs job preferred criteria include:
- Bachelor’s Degree in a Science/Technical discipline (life sciences)
- Master’s degree
- Experience working in a broader enterprise/cross-division business unit model
- Experience working in the Medical Device industry
- Regulatory Affairs Professionals Society Certification is a plus
Key Responsibilities
Regulatory affairs job responsibilities include:
- Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
- Creates, reviews and approves engineering changes.
- Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate staff.
- May interface directly with regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory submissions.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with regulations and regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
