Senior Regulatory Affairs Program Lead
Senior Regulatory Affairs Program Lead
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Job Description
The Sr. Regulatory Affairs Program Lead (Sr. RA Program Lead) provides administrative and technical support to regulatory affairs management in order to facilitate compliance with all FDA and other U.S. and international regulatory requirements throughout the product life cycle. The position provides direct Worldwide Regulatory support to lifecycle management (LCM) and new product development (NPD) cross-functional project teams including in-depth team involvement for complex projects; evaluation of proposed product modifications for global Regulatory impact; and documentation of required change impact assessments and Regulatory Strategies. The role assists in the identification and development of operational improvements of Regulatory Affairs processes.
Responsibilities:
- Ensures compliance with regulatory agency regulations and interpretations.
- Writes coordinates compiles and submits Regulatory documents to FDA and other Regulatory Agencies including EPA and International Authorities. Also includes the preparation of international documents including Technical Files and Technical Documentation.
- Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
- May lead functional teams or projects with moderate resource requirements risk and/or complexity.
- Provides solutions to problems with moderate complexity and risk. Works independently with guidance in only the most complex situations.
- Creates detailed Regulatory Plans. Includes in-depth team involvement including Core Team membership for complex projects.
- Evaluates proposed product modifications for Regulatory impact on a world-wide basis. Completes Regulatory Assessments as needed.
- Ensures compliance with FDA and other applicable regulations and standards.
- Ensures preparation of necessary outlines summaries status reports memos graphs charts tables and slides.
- Prepares responses to Regulatory authority questions as well as other Regulatory correspondence.
- May communicate and negotiate with regulatory authorities.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Requires use and application of Regulatory concepts practices and techniques.
- Provides regulatory guidance to cross-functional project teams.
- Participates in the development review and approval of product labeling.
- Provides support to inspections/audits by FDA the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.
- Review and approval of advertising and promotional materials.
- Communicates business related issues or opportunities to next management level.
- Uses appropriate elements of the Fortive Business System (FBS) and exemplifies the Fortive 9 behaviors.
- Responsible for communicating business related issues or opportunities to next management level.
- Performs other duties assigned as needed.
Qualifications:
- 6- 8 years of related work experience
- Minimum of 4 years of experience with MS or equivalent knowledge and skills necessary to satisfactorily perform the positions responsibilities.
- Proper application of Title 21 of the US Code of Federal Regulations
- Proper application of Part 800-1299 (21 CFR 800-1299)
- Proper application of US Federal Food Drug and Cosmetic Act (FD&C) Section 510(k)
- Proper application of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and
- European Medical Device Regulation (2017/745)
- Proper application of Quality Management System Standard ISO 13485
- Proper application of Risk Management Standard ISO 14971
- International Medical Device requirements (China Japan Canada Australia Brazil Russia etc.)
- Excellent written and oral communication skills
- Proficiency in Microsoft Office and related applications
- Good analytical thinking problem solving and investigative skills.
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Required Experience:
Senior IC
Employment Type
Full-Time
