[Remote] Regulatory Affairs Specialist - (APAC) at Penumbra Inc

Singapore

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Regulatory AffairsIndustries

Requirements

Bachelor's degree in a scientific discipline or related field with 3+ years of relevant regulatory experience in medical device or related industry, or equivalent combination of education and experience
Working knowledge of quality systems and ISO 13485, GDPMD (S), biocompatibility requirements and regulations, procedures and practices required by regulatory bodies for medical device industry activities such as filing and/or creation of premarket submission dossiers and other country specific product registrations
Demonstrated success creating, submitting, and making changes to domestic and international regulatory submissions, applying appropriate technical standards, principles, theories, concepts, and techniques
Strong oral, written, and interpersonal communication skills in English
High degree of accuracy and attention to detail
Proficiency with MS Word, Excel, and PowerPoint
Excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously
Ability to propose solutions and make regulatory decisions for the business
Willingness and ability to work on site if required, with business travel from 0% - 20%
Physical ability to lift and move up to 25 pounds, move between buildings and floors, remain stationary and use office equipment for extended periods, read, prepare emails, and produce documents and spreadsheets

Responsibilities

Prepare complex submissions with supervision to gain approvals for commercial distribution for countries in their sphere of responsibility
Communicate with regulatory authorities, regulatory consultants, and distributors to facilitate registration as deemed necessary
Perform research, identification of filing regulations, correspondence, scheduling, tracking, trending analysis, translation support, filing preparation and document maintenance for compliance with U.S. and international regulatory requirements
Track and ensure that existing product registrations are maintained and updated as required
Review and approve advertising/promotional materials and procedures to ensure regulatory compliance
Review and approve product and manufacturing changes and shipping release documents for compliance with applicable regulations
Provide interpretation of region-specific Regulatory Authority regulations and guidelines as needed to support accomplishment of organizational objectives; maintain up-to-date understanding of current and new regulatory requirements in existing markets and proactively identify regulatory requirements in prospective markets
Assist with Customs/Importation procedures to ensure timely movement of product
Partner with cross-functional team members to ensure that regulatory strategies are compliant, aligned with business objectives, and incorporated into the appropriate product development project phases
Assist in activities (e.g., execution, documentation) related to Field Corrective Actions
Participate in internal and external audits, including the monitoring and tracking of open non-conformances and observations

Skills

Key technologies and capabilities for this role

Regulatory ComplianceSubmission PreparationRegulatory FilingsDocument ManagementRegulatory ResearchQuality SystemsPromotional Material ReviewRegulatory Authority CommunicationRegistration MaintenanceCustoms Procedures

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor's degree in a scientific discipline or related field with 3+ years of relevant regulatory experience in medical device or related industry, or equivalent combination of education and experience is required.

What key skills and knowledge are needed for the Regulatory Affairs Specialist position?

Candidates need working knowledge of quality systems and ISO 13485, GDPMD (S), biocompatibility requirements and regulations, procedures and practices required by regulatory bodies for medical device industry activities such as filing and/or creation of premarket submission dossiers and other country specific product registrations.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Regulatory Affairs Specialist role?

Strong candidates will have demonstrated success creating, submitting, and making changes to domestic and international regulatory submissions, along with experience in medical devices.

Penumbra Inc

Develops medical devices for vascular conditions

About Penumbra Inc

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.

Alameda, CaliforniaHeadquarters

2004Year Founded

$116.7KTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Parental Leave

Paid Vacation

Paid Sick Leave

Paid Holidays

Risks

Recent layoffs in the Immersive Healthcare division may indicate financial strain.

The EMBOLIZE trial could divert resources from core product lines.

Regulatory challenges in Europe may impact sales of new products like BMX81 and BMX96.

Differentiation

Penumbra offers a comprehensive range of neuro and peripheral vascular devices.

The company focuses on innovative solutions for stroke and neurovascular disease treatment.

Penumbra's global presence spans North America, Europe, Asia, and Australia.

Upsides

Growing demand for minimally invasive procedures aligns with Penumbra's product offerings.

The global neurovascular devices market is projected to grow at 8.5% CAGR until 2030.

Penumbra's European launch of BMX81 and BMX96 expands its market presence.

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