STAFF REGULATORY AFFAIRS SPECIALIST
San Diego, CA 92101
Job Category: Legal - Regulatory / Compliance Law
Industry: Medical Equipment / Devices
Location: San Diego, CA
1.Develops global regulatory strategies for electro-mechanical and software product submissions.
2.Develops and maintains domestic and international submissions.
3.Reviews international and domestic labeling and marketing communications for compliance to labeling standards and product claims.
4.Reviews and approves product design changes.
5.Provides regulatory guidance to project teams including marketing, R&D and quality.
1.Prepares and maintains domestic and international regulatory strategies and submissions.
2.Participate as a core team member for development projects and works with cross-functional teams from multiple business units.
3.Review and approves product design and change documentation, including development plans and ISO 14971 risk management deliverables.
4.Reviews domestic and international labeling for compliance to labeling requirements, including content, format, regulatory submissions.
5.Provides regulatory review and approval for domestic and International product marketing communications
1.Bachelor's degree and minimum of 5-7 years related professional experience; equivalent combination of education and experience
2.Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications.
3.Knowledge of ISO / MDD and Canadian regulatory requirements.
4.Experience with software driven electro-mechanical medical devices, stand-alone software and IEC 62304 software development lifecycle.
5.Good prioritizing, organization, interpersonal, communication and analytical skills.
6.Ability to influence and work with personnel at all levels and functional boundaries.
7.Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.)
Ability to read, analyze, and interpret regulatory literature and documents.
Ability to format regulatory submissions that conform to prescribed style and format.
Ability to effectively communicate information to peers and management.
Ability to translate regulations and guidelines into terms that employees can understand.
Mathematical Skills: Ability to calculate figures and amount such as proportions, percentages etc.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions, furnish in written oral, diagram, or schedule form.
1.Security Clearance Not Required
2.Visa Candidates Not Considered
3.Competitive Base Salary & Full-time Benefits
4.Relocation Assistance Available for ideal candidate
5.Not Overtime Eligible - No
6.Interview Travel Reimbursed
7.5+ to 7 years of experience
8.Management Experience Not Required
9.Bachelor's Degree required
10.Willingness to Travel Occasionally (25%) to Denver
11.Ideal candidate will have 5-7 Years of experience. 510 experience - Class II OR PMA. Products that involve software. Highly knowledgeable with changes and requirements in the US
12.This position will work in or Medication Management Solutions business with Class II Infusion products that involve software.