Regulatory Affairs Specialists

Employment Type

: Full-Time


: Miscellaneous

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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)

Preferred Skills/Competencies:

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

General Comments

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.
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