Mumba Technologies, Inc.
Regulatory Affairs Specialist
Mumba Technologies, Inc., Sunnyvale, California, United States, 94087
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Overview
The Regulatory Lead serves as the primary regulatory representative and Subject Matter Expert (SME) within the functional group. The Regulatory Affairs Lead liaises with cross functional organizations, as well as global regulatory counterparts, focusing on product lifecycle management including supporting ongoing product changes and continuous improvement projects. Regulatory expert and SME on the product group, including classifications, indications, applicable regulatory standards and guidance docs., emerging regulations and regulators/industry perspective for the product group.
Providing regulatory guidance and direction, inclusive of potential risks, to cross-functional business partners and company leadership. Creatively identifies risk-based solutions and strategies for problem solving
Develop and recommend strategies for new product development and changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility.
Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
Assess the impact of the product/process changes and determine regulatory pathway for US and EU markets
Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications, and internal “Letters to File”, as applicable.
Core team RA functional lead acted as liaison between cross-functional team and international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals, and implementation roll-out
Provide risk-based guidance and strategic input into projects and issues and help facilitate cross functional alignment and resolution
Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams
Perform other duties as required
Qualifications
Skills, Experience, Education, & Training:
Education: Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degree with equivalent complex medical device experience acceptable
Experience: Minimum 10 years of experience in Medical Device industry with roles showing increasing responsibility and 5+ years of medical device regulatory affairs experience in US and submissions and EU technical documentation with solid knowledge of medical device regulations in regard to end-to-end product lifecycle management
In-depth understanding of US and EU Medical Device regulations
Extensive working knowledge of design controls, risk management, verification and validation, and product labeling requirements/documentation is required
Experience with complex products including mechanical, electrical, and software elements is a plus
Ability to work in a fast-paced environment and handle multiple projects simultaneously
Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
Team player who seeks to help and learn from colleagues seeing the department success as their own
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
Proactively seeks to develop and become well-versed within the regulatory landscape.
RAPS Regulatory Affairs Certification (RAC) is a plus
Seniority
Mid-Senior level
Employment type
Contract
Job function
Regulatory Affairs
Industries
IT Services and IT Consulting
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The Regulatory Lead serves as the primary regulatory representative and Subject Matter Expert (SME) within the functional group. The Regulatory Affairs Lead liaises with cross functional organizations, as well as global regulatory counterparts, focusing on product lifecycle management including supporting ongoing product changes and continuous improvement projects. Regulatory expert and SME on the product group, including classifications, indications, applicable regulatory standards and guidance docs., emerging regulations and regulators/industry perspective for the product group.
Providing regulatory guidance and direction, inclusive of potential risks, to cross-functional business partners and company leadership. Creatively identifies risk-based solutions and strategies for problem solving
Develop and recommend strategies for new product development and changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility.
Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
Assess the impact of the product/process changes and determine regulatory pathway for US and EU markets
Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications, and internal “Letters to File”, as applicable.
Core team RA functional lead acted as liaison between cross-functional team and international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals, and implementation roll-out
Provide risk-based guidance and strategic input into projects and issues and help facilitate cross functional alignment and resolution
Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams
Perform other duties as required
Qualifications
Skills, Experience, Education, & Training:
Education: Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degree with equivalent complex medical device experience acceptable
Experience: Minimum 10 years of experience in Medical Device industry with roles showing increasing responsibility and 5+ years of medical device regulatory affairs experience in US and submissions and EU technical documentation with solid knowledge of medical device regulations in regard to end-to-end product lifecycle management
In-depth understanding of US and EU Medical Device regulations
Extensive working knowledge of design controls, risk management, verification and validation, and product labeling requirements/documentation is required
Experience with complex products including mechanical, electrical, and software elements is a plus
Ability to work in a fast-paced environment and handle multiple projects simultaneously
Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
Team player who seeks to help and learn from colleagues seeing the department success as their own
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
Proactively seeks to develop and become well-versed within the regulatory landscape.
RAPS Regulatory Affairs Certification (RAC) is a plus
Seniority
Mid-Senior level
Employment type
Contract
Job function
Regulatory Affairs
Industries
IT Services and IT Consulting
#J-18808-Ljbffr