Hybrid Senior Regulatory Affairs Specialist presso Modular Medical

At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn’t have to be a tech expert or a math genius to take charge of your health. 

Please note: This is a three day on-site position is based in San Diego, CA. 

Role and Responsibilities:

• Provide accurate and consistent regulatory recommendations, decisions, and feedback to project teams
• Prepare regulatory strategies for new devices and post-market changes
• Clearly communicate strategies to RA management and core teams
• Prepare regulatory filings for new products, as well as significant post-market changes
• As necessary, review complex regulatory issues with RA management
• Identify risks within regulatory strategies and clearly communicate risks to project teams and RA management
• Negotiate and lead meetings directly with government entities (e.g., FDA, Notified Bodies, etc.) on regulatory filings at the reviewer level. All significant issues are negotiated with RA management.
• Lead and author multiple types of substantive regulatory filings such as PMAs, 510(k)s, EU Technical Documentation files
• Follow Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations
• Maintain proficiency in broad, regional regulatory requirements
• Develop general strategies on more effective interactions with government agencies and agency personnel
• Assist RA management with training of more junior staff
• All other duties as assigned

Education: Bachelor’s degree in Science, Engineering, or related technical field 

Experience:

• 4+ years of Regulatory Affairs experience within medical device or other highly regulated industries

Skills (Required):

• Ability to handle multiple tasks while ensuring timely and accurate completion
• Excellent communication, both written and verbal, as well as experience with communication to senior leadership
• Effective project management, interpersonal, analytical, communication, and organizational skills
• Strong working knowledge of current FDA medical device regulatory requirements, Quality System Regulation, ISO 13485, EU MDR, CE mark, and country-specific requirements, where applicable
• Must have working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions (CAPA)
• Basic working knowledge of engineering/quality statistics 

Skills (Preferred):

• Knowledge of medical device processes in the following areas: reliability, sterilization, usability, software, cybersecurity, biocompatibility, performance testing, etc.

Physical: 

• Ability to sit or stand for extended periods of time
• Ability to infrequently lift and/or move up to 35 pounds

Note: Only local applicants with the legal right to live and work in the US will be considered for this position.

Compensation: The pay range for this position is $120,000-$150,000 annually. The actual base pay offered may vary depending on several factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Additionally, we offer a comprehensive benefits package for our employees and their dependents, including medical, dental, vision, and life insurance, a generous PTO policy, and new hire stock options.

Application Policy: Modular Medical does not accept unsolicited resumes or applications from agencies. Please refrain from forwarding resumes to the Talent Acquisition team or employees. Modular Medical will not be responsible for any fees related to unsolicited resumes.

Equal Opportunity Employer: Modular Medical is an Equal Opportunity Employer. We embrace diversity and are dedicated to fostering an inclusive environment for all employees. We do not discriminate based on race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or any other legally protected characteristics.