Life Sciences Compliance and Regulatory Affairs Professional

We are seeking early to midcareer professionals to support global regulatory and ethics & compliance activities for our clients in the life sciences industry.

Key Responsibilities:

• Support regulatory strategy for new products and changes (devices drugs combination products digital health/SaMD).
• Help prepare FDA and international submissions (e.g. 510(k) Q-/PreSubs MDR/IVDR files) and maintain product registrations.
• Contribute to EU technical documentation (Technical Files CERs Declarations of Conformity).
• Help maintain and improve QMS (e.g. ISO 13485 FDA QSR GMP); draft/update SOPs and templates.
• Support internal and external audits CAPA activities and remediation.
• Assist with Code of Conduct and global policy development (e.g. antibribery HCP interactions conflicts of interest thirdparty risk).
• Help create and deliver training and communications (elearning live sessions guides intranet content).
• Support conflictsofinterest processes hotline and investigations tracking risk assessments and culture/engagement surveys.
• Partner with Legal Quality Medical Commercial HR Finance IT and others to review projects and contracts for compliance considerations.

Qualifications:

• Bachelors degree in a relevant field; JD or relevant advanced degree a plus but not required.
• 510 years experience in one or more of: regulatory affairs quality systems ethics & compliance or legal roles in pharma/biotech/medical devices/diagnostics.
• Strong writing and communication skills; ability to draft clear policies and training.
• Organized detailoriented and comfortable managing multiple projects and working crossfunctionally.
• Strong analytical and problem-solving skills.

Compensation Benefits & Location:

This role offers a range of competitive compensation starting at $125000 and a highly competitive benefits package in the alternative legal services marketplace that includes health benefits 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely with the exception that some clients require on-site presence.

Axiom is the global leader in high-caliber on-demand legal talent. Covering North America the UK Europe and APAC we enable legal departments to drive efficiency and growth and meet the demands of todays business landscape with best in breed alterative legal services.

Axiom is a leader in diversity inclusion and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ Equality earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axioms legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation.

Pursuant to the San Francisco Fair Chance Ordinance we will consider for employment qualified applicants with arrest and conviction records. Learn more about working at Axiom.

Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment without discrimination or harassment on the basis of race color nationality national or ethnic origin religious creed or belief political opinion sex gender reassignment pregnancy or maternity age disability alienage or citizenship status marital (or civil or other partnership recognized by law) status genetic predisposition or carrier status sexual orientation military service or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment.

Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form please contact us at and include Applicant Accommodation in the subject line.

Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used our full privacy notice is available at with Axiom may be contingent upon successful completion of a background check providing proof of identity and possessing the necessary legal authorization to work.

By submitting an application you acknowledge that all information contained therein and provided at any part of the application process is correct and accurate to the best of your knowledge.

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Required Experience:

Unclear Seniority