Regulatory Affairs Project Manager (Delivery System)

Job Title: Senior Regulatory Affairs Specialist
Supervisor/Manager Title: Senior Manager, Regulatory Affairs

Job Description Summary:
Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre- and post-market applications), query responses, and correspondence tracking. Maintains regulatory information for competitive intelligence, literature maintenance, and standards review programs. Interacts with internal departments and external representatives (e.g., distributors, legal agents, regulatory agencies). Translates regulatory requirements into practical strategy and planning documents. Provides guidance to project team members and regulatory staff. Supports serious adverse event reporting and post-market surveillance activities (complaints, MDRs, vigilance reports). Performs other duties as assigned.

Job Responsibilities:

1. Prepare technical documentation and regulatory submissions for investigational device applications, commercial registrations, annual reports, and supplements.
2. Provide regulatory strategy to product development and sustaining teams to meet global requirements.
3. Collaborate with Clinical, Marketing, R&D, Manufacturing, and Quality to develop technical, clinical, and labeling content.
4. Provide guidance and support to regulatory team members.
5. Communicate with regulatory authorities, legal agents, distributors, and suppliers to support approvals.
6. Assess document changes for impact on US, EU, and international regulatory filings.
7. Support standards review and interpret regulatory requirements for products, labeling, clinical studies, and processes.
8. Support adverse event reporting, MDRs, vigilance reports, and regulatory communications.
9. Review and approve risk analyses, protocols, reports, NCRs, and CAPAs.
10. Participate in internal and external audits.
11. Maintain and update regulatory procedures.
12. Perform other duties as assigned.

Qualifications
Required Education and Experience:

1. Bachelor's degree in a scientific discipline or equivalent.
2. 5 to 8 years of experience in medical device regulatory affairs.
3. Experience with Class III medical devices preferred.
4. Experience with EU MDR preferred.
5. Knowledge of quality systems and regulatory requirements.
6. Experience with global regulatory submissions and product development processes.
7. Ability to interpret regulatory standards and provide direction to project teams.
8. Ability to work in a fast-paced environment.
9. Ability to manage multiple priorities.
10. Strong problem-solving and interpersonal skills.
11. Technical writing experience.
12. Strong communication and organizational skills.

Skills and Abilities Required for This Job:

1. Communication, organization, and project management skills.
2. Ability to analyze data and support regulatory decisions and submissions.
3. Ability to work independently on routine activities.
4. Adaptability to changing priorities.
5. Sound judgment within defined procedures.
6. Professional communication and collaboration skills.
7. Proficiency in Microsoft Office.
8. Ability to lift up to 20 pounds