Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate global, regional, and multi-country regulatory strategies for both new and modified medical devices.

• Prepare both international and domestic filings and registrations within set timelines and organizational objectives.

• Anticipate potential regulatory challenges and emerging issues throughout the product lifecycle.

• Engage with regulatory authorities during development and review phases to facilitate submission approval.

• Represent the Regulatory Affairs department on assigned projects and offer regulatory guidance to cross-functional teams.

• Collaborate with international contacts regarding product modifications, regulatory notifications, and registration/license upkeep.

• Evaluate and approve product design alterations to ensure regulatory compliance.

• Draft or update SOPs to enhance Quality System regulatory conformity.

• Assess and approve advertising and promotional materials for global labeling consistency and market-specific compliance.

• Assist in managing product recalls and communications for products marketed internationally.

• Monitor the effects of evolving global regulations on submission strategies and registrations.

• Perform additional quality and regulatory-related tasks as assigned.

⛳️ Requirements

• A Bachelor’s degree (B.A./B.S.) is mandatory.

• A minimum of 3 years of experience in Regulatory Affairs within the medical device sector.

• Familiarity with global medical device regulations, including 21 CFR 820, MDD/CMDR, EU MDR, UKCA, Asia Pacific, and LATAM.

• Strong understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA, and other international regulations, directives, and standards is highly desirable.

• Required experience in product development or sustaining/lifecycle management.

• Outstanding written and verbal communication skills.

• Exceptional problem-solving abilities.

• Excellent organizational skills.

• Willingness to travel up to 10% as needed.

• A Master’s or other advanced degree in a relevant field is preferred.

• Experience with SaMD/MDSW, wearable, and OTC medical devices is highly preferred.

• Proficient project management skills.

🏝️ Benefits

• Medical, dental, and vision insurance starting on the first day of employment.

• Paid holidays.

• Paid time off (PTO).

• 401K plan with company matching.

• Employee Stock Purchase Plan.

• Paid parental leave.

• Discounted pet insurance.

• Opportunities to participate in Cultural Committee/Charity events.

• Reasonable accommodations for qualified individuals with disabilities during the job application process.