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Remote Regulatory Affairs Specialist II
Remote Tampa, FL 33607 US
Job Description
Job Description:
Must Haves:
Need to have good experience assessing the impact from changes to devices - US and EU and CAN.
510K Experience
Must be extremely organized, have to be good at time management and multitasking.
- Perform regulatory assessments for US, EU, and Canada for changes on commercialized medical device product
- Work with global regulatory affiliates to compile global regulatory impact for changes on commercialized medical device products
- Create submissions for US FDA and Health Canada as well as compile and maintain STeDs for changes on commercialized medical device products
- Coordinate and clearly communicate with team members to properly implement changes to medical devices
- Remediate product labeling and STeDs for EU MDR compliance
- Various other duties within the medical device regulatory lifecycle maintenance space
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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