As a Senior Regulatory Affairs Specialist, you are responsible for preparation and maintenance of both U.S. and foreign regulatory pre-market submissions and other premarket filings to acquire appropriate commercial distribution clearances in an expeditious manner, with a focus on products containing software. Each day offers exciting new challenges as you tackle a variety of tasks including:
- Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
- Ability to determine and communicate submission and approval requirements to others
- Control and maintain regulatory records.
- Represent Regulatory Affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs.
- Evaluate regulatory impact of proposed product and/or process changes, and determine if a new pre-market application is required.
- Ability to lead & organize project meetings and coordination of tasks to obtain required deliverables.
- Responsible for assisting Engineering in maintenance of Design History Files and related records on an as needed basis, and where regulatory responsibilities permit.
- Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
- Demonstrates global regulatory expertise in product submissions and ability to evaluate changes with local regulations.
- Must be detail oriented & highly organized.
- Must demonstrate teamwork building skills in & outside department.
- Ability to exercise judgment
- Ability to prioritize workload with limited direction
- Bachelor’s degree
- 5+ years of related experience, specifically in the medical device industry with focus on software devices and mechanical electrical equipment
- In depth understanding of Regulatory Affairs as it applies throughout the product lifecycle
- Strong understanding of pre-market submission types and requirements
- Understands regulatory terminology
- Strong knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
- In depth knowledge of labeling requirements per 21 CFR Part 801, 820, and ISO 13485, and EU Medical Device Directive and EU Medical Device Regulation
- Proactively assembles necessary information and establishes informal working networks within the company to solve departmental challenges.
- Understands requirements of project plans and focuses activities on meeting plan objectives.
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we’re here every step of the way to find your dream engineering job.
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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