regulatory affairs associate in Skaneateles Falls, NY

regulatory affairs associate - Randstad - Skaneateles Falls, NY - work from home job Company: Randstad Job description: job summary: Leader in medical device manufacturing is looking for Regulatory Affairs Associate in Skaneateles, NY for a contract role expected to last 12 months, possible extension, possible temp to perm. This role can be fully remote (USA) or hybrid. The Regulatory Affairs Coordinator is responsible for preparing and managing documents for medical device regulatory submissions, ensuring compliance with EU MDR requirements, and maintaining effective communication with regulatory authorities, utilizing strong scientific knowledge and technical skills. location: Skaneateles Falls, New York job type: Contract salary: $53.00 - 58.80 per hour work hours: 8am to 5pm education: Bachelors responsibilities: • Coordinate and prepare documents/packages for medical device regulatory submissions. • Review and evaluate technical and scientific data and reports required for regulatory submissions. • Track the status and progress of regulatory documentation. • Review, edit, and proofread regulatory documentation. • Assist in the preparation and review of labeling, SOPs (Standard Operating Procedures), and other departmental documents. • Compile regulatory documents for submission under supervision. • Participate as an active team member in project teams as required. Skills: • strong scientific knowledge. • Excellent written and verbal communication skills. • Knowledge of regulations related to medical devices. • Technical systems skills (e.g., word processing, spreadsheets, databases, online research). • Proficiency in proofreading and editing. • Ability to contribute to multiple projects from a regulatory affairs perspective. • Ability to multitask and prioritize. Education and Experience: • Bachelor's degree or equivalent in chemistry, biological sciences, regulatory affairs, or a related scientific discipline. • 3-5 years of regulatory experience, preferably within a medical device and technology environment. qualifications: • Experience level: Experienced • Education: Bachelors skills: * Regulatory Affairs / Compliance • Documentation Control • Research & Development • Medical Device Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Expected salary: $53 - 58.8 per hour Location: Skaneateles Falls, NY Job date: Mon, 04 Sep 2023 23:20:26 GMT Apply for the job now! Apply tot his job Apply tot his job