Compliance Officers QA & RA: What They Do and Why They are in Demand.

Every businesses workhas  complex compliance requirements, from anti-money laundering laws to consumer protection, labelling safety and environment protection.Similarly, there is very highly regulated pharmaceutical industry and medical device business must comply not only local laws but also of the countries where they are exporting. This compliance is not just on product quality claim by manufacturer but must meet all requirement like manufacturing its environment, testing, various other actual testing on human called clinical trial where needed.

Business must comply with all compliance requirement otherwise consequences are severe like not just financial loss, business closure but also punishment of imprisonment to certain direct people.

Let us talk about Medical device business compliances.

They are majorly divided into two areas where manufacturing compliance requirement is there and other is directly dealing with regulatory authorities’ time to time basis for ever changing compliance needs and keep them aware of your products performance issue (like adverse event) and how you resolve them as per laid down guidelines.

In medical device field the first type of role is majorly played by Quality assurance person while the other has major role to play is called Regulatory Affairs (RA)

Both QA and RA must interact very frequently and device strategy to deal routine business as well as issue handling situation.

What are the typical duties of compliance officers? Called QA and RA

Compliance officers are liable for ensuring their organization complies with government regulations — domestically also as globally, if applicable — and avoids missteps that would lead to hefty fines, legal ramifications and reputation damage. Compliance officers also got to confirm that employees are following internal compliance policies.

• Developing, implementing and managing an organization’s compliance program. Which involves Good manufacturing practices (ISO 13485 is one of the best and well accepted standards for all to follow)
• Coordinating with federal and state regulators for regular approval of products, coordinate with various agencies for various study like clinical study. For handling submitting periodic data needed. Adverse event reporting, product re-call compliance.
• Planning, implementing and overseeing risk-related programs. Risk based approach is well accepted by federal and local authorities hence this has become norm. Ensuring that standard risk- based system is established, people are trained, and organisation then follows the same.
• Creating and coordinating proper reporting channels for compliance issues within organisation so resolution is timely and effective. Like product Re-call system is mandatory but if designed and established properly as per business spread geography, system works effectively in event handling. Even though such event may be one in five year or none for long period because other systems are designed to prevent such event to occur.
• Developing company compliance communications and keeping all required people aware of changes even though it may not affect present scenario.
• Coordinating and scheduling required compliance training for employees. Training is one of the mandatory parts of ISO 13485.

Skills compliance officers need to succeed.

Normally QA and RA both are highly specific skills person acquires during work experience.

Most companies have full time QA organisation and Full time RA compliance officer or department based on complexities of business. Sometime some role of RA is outsourced through consultants.

QA must be on full time role as per regulatory requirement because product release to market goes under his/her signature only.

Whether they are working during a full-time role or on a consulting basis, compliance officers must have strong knowledge of federal and state regulatory guidelines and standards. They also got to monitor  through regular audit so. audit techniques.

Developing and Establishing Good manufacturing practice guidelines as per ISO 13485 and incorporating other countries such requirement into system, hence in-depth knowledge of this area at least for QA compliance officer.

Industry experience are often a key attribute also, particularly in highly regulated areas like US FDA, European MDR, Australian TGA, While the details of specific mandates are often learned, companies can enjoy hiring compliance officers who are intimate the broader regulatory landscape for their specific sector.

While both GMP and regulatory skills are necessities for compliance officers, these professionals should even have a solid mixture of soft skills, including leadership abilities. Expert communication and speechmaking skills are needed to facilitate a far better organizational understanding of complex regulatory standards. Integrity and a history of ethical decision-making also are essential.