Orion Group Life Sciences are currently recruiting Senior Regulatory Compliance Specialist on behalf of our Multinational Medical Device client based in Ringaskiddy, Cork on an initial 12-month contract.
The Regulatory Compliance Specialist is responsible for establishing and maintaining a robust Compliance Program for the manufacturing sites under their scope of responsibilities, in order to ensure compliance to local, national and international regulatory standards, company policies, procedures and corporate requirements.
- Establish and maintain robust compliance program ensuring compliance to local, national and international regulatory standards, company policies and procedures, and corporate requirements.
- Establish and maintain regulatory inspection readiness plan at manufacturing site within the scope of responsibilities, in preparation for any regulatory inspection (internal and external).
- Supports manufacturing site regulatory inspections and acts as Subject Matter Expert on Internal Audit process for any site External Inspection.
- Partnership with Compliance teams in order to coordinate the implementation of internal and external audit schedules. Perform the audits to support the program as required.
- Enable successful product realization and compliance through readiness compliance activities, assessments and other consultation.
- Partnership with the site on the formulation of robust responses to regulatory agencies in order to address manufacturing related observations. Collaborate with other business partners in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions.
- Track 3rd party, notify body or corporate inspection commitments timeliness and inform regularly local/regional management accordingly.
- Establish and maintain programs that ensure the verification and monitoring of the effectiveness of the Franchise quality system and its compliance to applicable regulations and standards.
- Ensure results of monitoring process are routinely communicated to management through Site Management Review process.
- Provide leadership, oversight and strategic guidance from the sector perspective for significant regulatory compliance issues in the manufacturing sites. Oversight may include independent monitoring and reporting.
- Provide input on the classification of all Regulatory Health Authority inspections and supply chain-related observations at EU Supply Chain manufacturing sites.
- Coordinate compliance training as required.
- Manage, schedule and participate in the Data Integrity (DI) audit programme.
Notified Bodies Relationship
- Assure all external auditing companies meet internal requirements prior to executing any portions of the contracting agreement.
- Collaborate with US and oUS compliance team to standardize and leverage compliance initiatives, practices and metrics across the organization.
- Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
- Support an MD framework and network of subject matter experts providing input to, appropriately influence, and interpret requirements of, Regulatory Agencies around the globe regarding regulations, regulatory pathways, or approaches.
- Support Franchise Compliance to identify, prioritize and ensure implementation of new and revised regulatory requirements and expectations.
- Support implementation plans for regulatory changes including routinely monitoring and verification of implementation activities.
- The Regulatory Compliance Specialist is responsible for coordination and deployment of any changes to regulation and standards.
- Manage departmental budget.
Key Qualifications and Experience:
- A minimum of a Bachelor's degree is required in science, engineering, or equivalent is strongly preferred. Post Graduate Qualification in Quality / Regulatory preferred.
- A minimum of 5 years of relevant experience in the Quality and Regulatory Compliance in the medical device/pharmaceutical industry.
- Strong knowledge of quality and compliance in a regulated manufacturing environment (GMPs).
- Working knowledge of Quality System Regulations.
- Prior experience managing External Regulatory and/or Notified Body Inspections (e.g., FDA, BSi etc) is preferred.
- Experience in auditing to FDA QSR, MDSAP and ISO 9001/ISO 13485 standards, additionally a working knowledge of other related medical device national regulatory standards
- ISO Lead Auditor or Lead Assessor Certification, preferred.
- Demonstrated knowledge of business impact of compliance issues and risk management.
- Experience in preparing for & managing external third-party audits.
- Proven ability to build partnerships both internally and externally.
- Proven ability to initiate and implement Quality System changes.
- Strong Project management skills and Change management experience.
- Compliance experience and reputation, large-scale QMS experience.
- Strong analytical skills and experience implementing risk-based oversight programs across multiple sites or corporate experience.
- Strong executive presentation skills.
- Issue remediation experience.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.