Regulatory Affairs Associate - Positive Work Culture

Description:
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.

Brief synopsis of what the worker will be doing:
The role is to support the transition of Client's Alinity and ARCHITECT Clinical Chemistry and Immunoassay products to CE marking under IVDR, plus supporting changes and country requests.
Involves reviewing and approving the technical file chapters used in the submissions to the European notified body.
Sending notifications to countries to inform of changes following IVDR transition and completing the implementation.
Attending meetings to provide the product status and functional area input.
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
Summarize the main purpose of the 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.

Top 5 skills/requirements HM would like to see:
Good communication skills, organised, able to cope with changing timelines and priorities, attention to detail, a knowledge of the IVDR

Experience Required
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.
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.
Note: This knowledge may be developed through tenure in this position.

Education
Bachelors Degree ( 16 years): 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

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

Confirm interview preferences : video (two rounds, if applicable)