Regulatory Affairs Specialists
Employment Type: Full-Time
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The Sr. Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including data and information analysis. Additionally, the ideal candidate will provide regulatory support to marketed product and ensure regulatory compliance.
Prepare and submit applications to the FDA and other regulatory bodies for new or modified software-based medical devices (e.g. 510(k)s, IDEs, PMAs, Qsubs, technical files)
Support in determination of regulatory requirements and strategies for new or modified software-based medical devices. Prepare required documentation as needed (e.g. Letter to file)
Represent Regulatory Affairs on project teams and provide direction regarding regulatory strategy. Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc.
Establish internal systems to ensure regulatory approval and continued compliance of medical devices in both domestic and international markets
Assess organizational and product impact when regulations, directives, guidance, or standards change
Interact and negotiate with regulatory authorities in support of device clearance activities
Review, evaluate and approve Engineering Change Orders (ECO) for regulatory impact especially those concerning significant changes and revisions
Review and evaluation product and promotional labeling for compliance with applicable regulations
Maintain Regulatory records
Performs other duties as required
B.S. / B.A.
Specialist: 2+ years of regulatory medical device industry experience (510(k)s, Qsubs, CE mark, IDEs, PMAs). Sr. Specialist: 4+ years of regulatory medical device industry experience (510(k)s, Qsubs, CE mark, IDEs, PMAs)
Experience with software-based medical devices and cybersecurity is preferred
International regulatory experience (e.g. Health Canada, TGA) is a plus
RAPS (RAC) Certification is a plus
Must have analytical skills, be detailed oriented and have good interpersonal skills
Knowledge of global regulatory guidelines and requirements
Effective verbal and written communication skills
Ability to communicate at multiple levels of an organization
PC skill, word processing, spreadsheet, database
Ability to organize and manage multiple priorities
Ability to generate and maintain accurate records
At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as: engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales.
Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire.
Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor.
- provided by Dice
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