Job Description
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 will execute tasks to evaluate product and software changes in consideration of regulatory guidance documents and regulations. 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.
•Evaluate proposed software, hardware and manufacturing changes for regulatory filing strategies.
•Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
•Participate in risk benefit analysis for regulatory compliance.
•Determine and communicate submission and approval requirements.
•Assist in preparation and review of regulatory submission to authorities.
•Assist compliance with product postmarketing approval requirements.
•Submit and review change controls to determine the level of change and consequent submission requirements.
•Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and on-time delivery of project milestones. Establishes priorities of work assignments.
•Establishes and cultivates an extensive network of support to facilitate completion of assignments.
•Participates in determining goals and objectives for projects.
•May organize and lead team meetings.
•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 (±6 years) In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
an equivalent combination of education and work experience
Experience Details:
Minimum 2 years. This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products,medical device software) or 2 years’ experience in software verification/validation, software quality assurance or experience as Medical Technologist with familiarity of software-driven clinical analyzers. Regulatory area with software knowledge is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Regulatory area with software knowledge 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); 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 is a plus (such as RAC from the Regulatory Affairs Professionals Society or Medical Technologist; ASCP.)
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.
Pay ranges between $25-30/hr based on experience
Job Tags
Contract work, Work experience placement, Worldwide,