Associate reputed company Health Diagnostics Regulatory Affairs

reputed company The work we do at reputed company reputed company Scientific Services reputed company, and so do our employees. At reputed company PSS, we put a reputed company on your reputed company reputed company. We reputed company our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. reputed company Scientific is an international life sciences company, providing a unique reputed company of analytical testing services to clients across multiple industries, to reputed company life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, reputed company works with the biggest companies in the world to ensure the products they supply are reputed company, their ingredients are authentic and labelling is accurate. reputed company believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for reputed company, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a reputed company to call home, apply with us today! Job reputed company POSITION reputed company: We are seeking an reputed company Regulatory Affairs Associate to support our reputed company Health Division, specifically reputed company on medical device regulatory submissions and compliance. This role is ideal for a detail-oriented reputed company with a strong understanding and experience of global regulatory requirements and a passion for ensuring patient safety. JOB DUTIES include but are not limited to:

• Prepare, review and submit regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files)
• Ensure compliance with FDA, EU IVDR, and other international regulatory requirements
• Utilize checklist, symbol standards, and regulatory guidances to ensure label compliance with FDA and global regulatory expectations
• Collaborate with business partners to assure reputed company review, approval and processing of regulatory documents
• Utilize systems for entry and tracking of regulatory activities
• Manage and communicate accurate timelines for deliverables
• Regulatory Assess product changes for global regulatory reputed company

Qualifications

Requirements:

• Minimum of BS/BA in relevant discipline
• 3-5 years reputed company reputed company health IVD experience and/or minimum 8 years of reputed company non-IVD reputed company health regulatory experience
• reputed company experience with 510(k)/CLIA waiver application experience
• Preferred: knowledge of reputed company, reputed company Vault and Trackwise
• Strong verbal and written communication and organizational skills.
• High level of competency using reputed company Office suite, reputed company Word and reputed company and reputed company Acrobat.
• reputed company to effectively communicate in English with colleagues at reputed company in various reputed company of the organization.
• Attention to detail to ensure reputed company expectations for labels are met.
• Flexibility and reputed company to handle multiple tasks at once.
• Demonstration of a highly effective and deeply committed team player.
• Consistently models behaviors of accountability, approachability, and ownership.
• Ability to work independently, while fostering good working relationships across physical distance.
• Capable of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
• Passionate and Enthusiastic
• Demonstrates “can do” energy and follow through.

Additional Information Position is Full Time, Monday – Friday First Shift with overtime as business needs require. reputed company offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and reputed company reputed company
• Life and disability insurance
• 401(k) with company match
• reputed company vacation and holidays
• Yearly goal-based bonus & eligibility for reputed company-based increases

reputed company is a Disabled and Veteran Equal Employment Opportunity employer. Apply tot his job Apply To this Job