Regulatory Affairs Specialist - (APAC)

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for research, preparation, coordination, filing and maintenance of document package submissions for new products and changes to existing products, in compliance with regulations and procedures required by regulatory bodies. The Regulatory Affairs Specialist APAC will ensure regulatory compliance and optimization of quality system procedures.

• 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 the following activities in support of submissions: 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.

 

• 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.

• 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.

 

General office environment. Willingness and ability to work on site if required. May have business travel from 0% - 20%. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for research, preparation, coordination, filing and maintenance of document package submissions for new products and changes to existing products, in compliance with regulations and procedures required by regulatory bodies. The Regulatory Affairs Specialist APAC will ensure regulatory compliance and optimization of quality system procedures.

• 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 the following activities in support of submissions: 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.

 

• 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.

• 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.

 

General office environment. Willingness and ability to work on site if required. May have business travel from 0% - 20%. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

 

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

 

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

 

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.