Regulatory Manager

Strukmyer Medical, a leading medical device contract manufacturing company, is seeking a detail-oriented and skilled Regulatory Manager to join our dynamic team. As a Regulatory Manager, you will play a crucial role in ensuring the highest standards of quality and safety for our medical products.

The Regulatory Manager has the primary responsibility to navigate complex regulatory landscapes, interpret laws and guidelines, and implement compliance strategies.

The responsibilities of the Regulatory Manager include:

• Translate regulatory requirements (e.g. FDA, ISO) into actionable policies, procedures, and compliance initiatives.
• Lead internal and external compliance audits and assessments to evaluate adherence to regulatory standards, contractual obligations, and internal policies. Identify areas of non-compliance or potential risks and develop corrective action plans to address deficiencies.
• Maintain accurate and up-to-date documentation related to regulatory compliance activities, including audit findings, remediation efforts, and compliance reports.
• Prepare and submit regulatory filings, disclosures, and reports as required by applicable laws and regulations.
• Serve as the primary point of contact for regulatory inquiries, inspections, and audits. 
• Monitors and assesses the effectiveness of the Quality System by measuring analyzing, managing the internal audit program, interpreting, and reporting on Quality System performance to the Site Leadership Team, and at periodic Management Review meetings, as required.
• Develop and write SOP & Controlled Documents to remediate or mitigate risks in the quality system.
• Assisting in, and facilitating, investigations as part of the site Quality Management System, ensuring effective root cause analysis and assigning of appropriate NCs, CAPAs, SCARS and deviations.
• Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.
• To actively support the development/implementation and continuous improvement of the Quality Management Systems.
• To be cross trained in multiple quality systems and responsible for Site Records Management, and oversight of the Quality Records Management Library.
• Participate in other projects as directed by the Head of QA/RA.

Job Requirements:

Bachelor's degree in Engineering, Chemistry, Biology or a related scientific discipline.

A minimum of 3 years working within regulatory compliance in the pharmaceutical or medical device industry.

Experience working in finished product medical device/pharmaceuticals manufacturing environment is preferred.

Experience and knowledge of medical device and pharmaceutical regulations (i.e., 21CFR Part 820, 210, 211 and ISO 13485).

Experience in managing external compliance audits (e.g. FDA, ISO).

Must have excellent written and verbal communication skills.

Demonstrated attention to detail and ability to prioritize and manage multiple tasks in a fast-paced environment.

Ability to work within cross-functional teams and influence stakeholders at various levels of the organization.

ASQ or other related certifications is strongly preferred.

Physical/Mental Requirements:

Must be able to work effectively under pressure and meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.