Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Job Description
A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Specialist role.
Our client, a leading medical device company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you.
Responsibilities include :
1) Responsible for the review, maintenance and monitoring of documentation related to the device's regulatory compliance, such as technical files, design dossiers, and labeling requirements
2) Identify regulatory pathways for initial product designs and provide input to internal stakeholders in preparation of FDA 510 K and De Novo submissions using a risk-based approach
3) Analyze and communicate the adequacy of proposed regulatory pathways and strategy for initial product designs and recommend changes or refinements based on initial regulatory outcomes
4) Write and review regulatory documents with a critical eye for suitability for submissions to the FDA and any other regulatory agencies as needed
5) Handle the preparation of electronic submission packages for regulatory agencies in compliance with applicable requirements and best practices
6) Evaluate regulatory policy and critically assess the impact of changing regulations on pre-approval and post-approval strategies and approach and advise internal stakeholders on a course of action
7) Participate in multidisciplinary project teams within the US Market Access Department providing guidance and direction on current regulatory pathways and expectations
8) Stay current on changes to the regulatory environment that could impact new product submission strategies
9) Work closely with quality assurance and quality control teams to establish and maintain appropriate quality systems for IVDs
10) Establish working relationships and interface with multiple government and non-government organizations having an impact on market access and distribution
11) Identify the need for and manage the development and execution of new regulatory procedures and standard operating procedures
12) Frame issues with a thorough understanding of legislation, regulations, guidance, policy and directives
13) Create work plans with appropriate staging of activities and with clearly defined milestones
14) Remain up-to-date on scientific and clinical advances that impact healthcare product development and assess the relationship to regulation and regulatory issues
15) Provide strategic input and technical guidance on global regulatory requirements to product development teams
16) Work with a document control group to ensure regulatory document archiving
17) Evaluate risks of product and clinical safety issues during clinical phases and recommend regulatory solutions
18) Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and propose plans for changes that do not require submissions
19) Review and assess proposals to regulatory authorities on regulatory paths and clinical plans
20) Ensure clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
21) Participate and lead key negotiations and interactions with regulatory authorities during all stages of the development and review process
22) Establish and maintain business relationships with officials in federal and state government regulatory agencies
23) Perform other related duties as assigned
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs
If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply we want to hear from you!
Compensation and Other Details
Base Salary : Highly competitive package, commensurate with experience
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