Senior Regulatory Affairs Specialist

We bring you tomorrows opportunity today

Volt is immediately hiring for Senior Regulatory Affairs Specialist in Pacheco CA 94553.

As a Senior Regulatory Affairs Specialist you will:

Responsibilities:

• We are seeking an experienced and detail-oriented Senior Regulatory Affairs Specialist to support global regulatory compliance and market access activities for our In Vitro Diagnostics (IVD) product portfolio.
• This role is responsible for managing international regulatory submissions maintaining product registrations supporting product development initiatives and ensuring continued compliance with global regulatory requirements.
• The ideal candidate will have a strong background in IVD regulations international market registrations and post-market compliance activities.
• This position works closely with cross-functional teams including R&D Quality Manufacturing Operations and Commercial teams to ensure regulatory requirements are integrated throughout the product lifecycle.
• Regulatory Strategy & Submissions:

• • Prepare coordinate and submit regulatory documentation and product registrations for key global markets including the United States European Union Canada Latin America Asia-Pacific Middle East and MDSAP-participating countries.
  • Manage product registrations listings licenses renewals and regulatory approvals to maintain uninterrupted market access.
  • Provide regulatory strategy and guidance for new product introductions and lifecycle management activities.
  • Coordinate activities with international consultants distributors and in-country regulatory representatives.

• Product Development Support:

• • Partner with R&D and Quality teams throughout the product development lifecycle from concept through commercialization.
  • Provide regulatory input regarding design controls risk management verification and validation activities labeling and change control.
  • Assess regulatory impact of product and process changes and support implementation activities.
  • Regulatory Compliance
  • Maintain technical documentation including Technical Files General Safety and Performance Requirements (GSPR) Clinical Evaluation Reports (CER) risk management files and supporting regulatory records.
  • Ensure compliance with applicable regulations and standards including IVDR FDA requirements ISO 13485 ISO 14971 and MDSAP.
  • Monitor changes in global regulations and perform regulatory impact assessments and gap analyses.

• Post-Market Surveillance & Vigilance

• • Support complaint investigations adverse event reporting recalls advisory notices and Medical Device Reporting (MDR).
  • Lead or support Post-Market Surveillance (PMS) activities including trend analysis vigilance reporting and documentation updates.
  • Develop and execute Post-Market Performance Follow-up (PMPF) activities and contribute data to Clinical Evaluation Reports and risk management documentation.
  • Support CAPA investigations and implementation of corrective actions.

• Quality Systems & Audits:

• • Collaborate with Quality Systems to ensure compliance with GMP/QSR ISO 13485 and MDSAP requirements.
  • Support internal audits external audits inspections and notified body assessments.
  • Prepare documentation and responses to regulatory agency and auditor inquiries.
  • Training & Continuous Improvement
  • Develop regulatory procedures templates guidance documents and training materials.
  • Deliver regulatory compliance training to internal stakeholders.
  • Participate in continuous improvement initiatives to strengthen regulatory processes and documentation quality.

This is afull time contractopportunity.

The ideal candidate will have:

Required Skills & Qualifications:

• Bachelors degree in Life Sciences Regulatory Affairs Biomedical Engineering Chemistry Biology or related field.
• Minimum of 3 years of regulatory affairs experience within the medical device or IVD industry.
• Experience preparing and supporting international regulatory submissions and product registrations.
• Working knowledge of: EU IVDR 2017/746 FDA regulations ISO 13485:2016 ISO 14971:2019 MDSAP requirements Global regulatory frameworks

Preferred Qualifications:

• Experience with international submissions in Europe Latin America Asia-Pacific and MDSAP markets.
• Experience with antibody-based diagnostic products.
• Regulatory Affairs Certification (RAC) preferred.
• Experience working with electronic Quality Management Systems (eQMS) such as MasterControl AssurX or Veeva Vault QMS.

Pay range: $50.00 - $52.89 per hour.

*Pay range offered to a successful candidate will be based on several factors including the candidates education work experience work location specific job duties certifications etc.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information and we will be back in touch as soon as possible.

Benefits: Volt offers benefits (based on eligibility) that include the following: health dental vision term life short term disability AD&D 401(k) Sick time and other types of paid leaves (as required by law) Employee Assistance Program (EAP).

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race color religion or belief national origin citizenship social or ethnic origin sex age physical or mental disability veteran status marital status domestic partner status sexual orientation or any other status protected by the statutes rules and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment please email or call (866). Please indicate the specifics of the assistance needed.

Volt does not discriminate against applicants based on citizenship status immigration status or national origin in accordance with 8 U.S.C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance the Los Angeles Fair Chance Initiative for Hiring Ordinance and other applicable laws.

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