Regulatory Affairs Specialist - Lake Bluff, United States - DivIHN Integration

Description

DivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
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Rashi at

Title: Regulatory Affairs Specialist
Location: Abbott Park, IL
Duration: 7 Months

Description
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others.
A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.

Main purpose of role
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

Main Responsibilities
Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Assist in preparation and review of regulatory submission to authorities.
Maintain annual licenses, registrations, listings and patent information.
Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional items.
Assess external communications relative to regulations. Review regulatory aspects of contracts.
Assist with label development and review for compliance before release.
Submit and review change controls to determine the level of change and consequent submission requirements.
Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.
Provide regulatory input for product recalls and recall communications.
Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.
Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Participates in determining goals and objectives for projects.
Influences middle management on technical or business solutions.
May interact with vendors.
Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

Education
Bachelors Degree ( 16 years), In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

Experience/ Background
Minimum 2 years, This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; 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; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.
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.
Pay strong attention to detail.
Manage projects. Create project plans and timelines.
Think analytically and critically.
Organize and track complex information.
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Has a sound knowledge of a variety of alternatives and their impact on the business.
Apply business and regulatory ethical standards.

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

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.