Regulatory Affairs Specialist
Job Title: Regulatory Affairs Specialist
Department: Quality Assurance and Regulatory Affairs
The primary responsibilities of this position will be premarket regulatory activities to support U.S. and international filings. Responsibilities include creating regulatory strategy for new products, supporting submission related activities, and interfacing with outside regulatory agencies. This position reports to the Director of Quality Assurance and Regulatory Affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Support assigned U.S. and international product/software registration activities; including assisting with the development of the regulatory strategy, 510k and international filing determinations, Technical Files, and international product registrations,
- Compile information from multiple sources for submissions, providing support to the project teams in creating documentation for submissions and assuring compliance with Design Control and Software Life Cycle SOPs.
- Assisting with writing summaries and other necessary documentation for submissions.
- Prepare annual licensing renewals and product registration and listings.
- Review and revise quality system related procedures and policies for Regulatory Affairs, as required.
- Provide guidance in complying with regulations; assist in developing rationale and documentation for new software and/or product development, software and/or product changes, testing, design reviews, labeling changes, packaging changes, material changes, etc.
- Review and approve product labeling and promotional materials in accordance with global regulations.
- Represent Regulatory Affairs on product and/or software development project teams, attending project team meetings providing regulatory guidance and review.
- Review and approve software/product regulatory document change orders.
- Review and approve Marketing advertising and promotional materials.
- Assist the Product Safety Team with making product safety determinations and submission of Medical Device Reports (MDR) and Vigilance activities in a timely manner.
- Assist with product corrections and removals in a timely manner.
- May interface with FDA and international regulatory agencies on regulatory issues.
- Assist management in planning regulatory activities, identifying roadblocks, and strategizing on various regulatory paths for new products or software.
- Work with Quality, Operations, Engineering, and Marketing to ensure compliant product supply.
Other duties may be assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to work independently.
- Team player – project team experience.
- Ability to do research and help with creative solutions for regulatory challenges.
- Excellent writing skills and ability to synthesize information to present internally as well as to regulatory agencies.
- Attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects.
EDUCATION and/or EXPERIENCE
- BA in Engineering or Science or equivalent years of work experience.
- RAPS RAC a plus.
- 2+ years in a regulatory role at a medical device company.
- Experience with FDA 510(k) submissions, international regulatory product registrations, reviewing documentation for regulatory compliance, and interfacing with ISO Notified Bodies.
- A working knowledge of Quality System regulations for medical devices (21 CFR 820, ISO 13485, CMDCAS, MDD, JPAL, etc.).
- A working understanding of risk management for medical devices (e.g. ISO 14971).
- Software-related regulatory experience preferred (e.g. knowledge of IEC 62304, FDA Software Guidance documents).
- Experience with maintaining Technical files to support MDD compliance.
- Knowledge of FDA regulations (e.g. 21CFR 801, 803, 806, 821) and international regulatory requirements.
- Computer skills including Word and Excel.
We are an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We also respect your privacy. Our Applicant Privacy Policies can be found here: http://jobs.jobvite.com/align-tech/
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