Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Present alternatives for meeting regulatory requirements and resolve conflicts between those requirements and development issues, and/or reporting to management.
Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions.
May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, Japan PMDA, other global regulatory agencies, submissions, dossiers and technical files)
Provide guidance on regulatory requirements necessary for contingency planning
Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process
. Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
Prepare documents for submissions to global regulatory bodies.
Experience:
Experience with EU MDR preferred
Coursework, seminars, and/or other formal government and/or trade association training required
Proven expertise in Microsoft Office, Adobe.
Experience in product lifecycle management systems (Agile, Teamcenter etc.) preferred
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Additional Skills:
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Ability to build productive internal/external working relationships
Develops solutions to a variety of problems of moderate scope and complexity
Contributes to process improvements
Exercise judgment within defined procedures and practices to determine appropriate regulatory action/requirements for new products or product changes and preparation of regulatory documents.
Education and Experience:
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
2-4 years of experience required.
CPRA: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $41.65/hr.
