Regulatory Affairs Specialist
Teleflex
full-time
Posted on:
Location Type: Office
Location: Wyomissing • Pennsylvania • United States
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About the role
- Participate in multidisciplinary teams and communicate regulatory requirements effectively
- Provide regulatory input to product lifecycle planning
- Obtain and evaluate regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices
- Conduct appropriate research to develop strong regulatory strategies for new products
- Determine issues that may create regulatory obstacles and investigate solutions
- Prepare and submit applicable regulatory documentation, as required (with focus on the US, EU and Canadian markets) and/or compile necessary documentation as requested by International Regulatory Affairs personnel
- Monitor progress of submission reviews and interact with regulatory agencies, as appropriate
- Participate in risk management assessments
- Review and approve product labeling, advertising, and promotional information for regulatory compliance
- Assist with SOP development and implementation
- Maintain regulatory information systems
- Support device import/export and distribution control activities
- Support regulatory compliance initiatives
- Monitor the impact of changing and evolving global regulations on submissions, practices, and procedures, and communicate to appropriate personnel
- Other duties as assigned by the Regulatory Affairs management team
- Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures, and housekeeping standards
Requirements
- Associate or Bachelor’s degree, preferably in the science or engineering disciplines
- Must have 2-5 years in a medical device organization, preferably in regulatory affairs
- Previous US, Canadian, and EU submissions experience preferred
- RAC certification preferred
- Ability to apply business and Regulatory Affairs ethical standards; analytical and critical thinking skills
- Proficient in Microsoft Office Suite
Benefits
- Up to 10% expected travel
- Equal opportunity employer
- Comprehensive hiring process
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory documentationregulatory strategiesrisk managementregulatory complianceregulatory submissionsdesign and manufacturing changesproduct lifecycle planninglabeling reviewSOP developmentregulatory information systems
Soft Skills
communicationanalytical thinkingcritical thinkingproblem-solvingteam collaborationattention to detailethical standardsinterpersonal skillsorganizational skillsadaptability
Certifications
RAC certification