• Posted date 29 November 2022
• LocationCounty Kilkenny
• Job type Permanent

• SalaryNegotiable
• Discipline Life Sciences
• ReferenceJO-2211-506222

Regulatory Affairs Manager

Medical Device

Kilkenny

In this role you will be in charge of managing teams within the Regulatory Affairs Sub-Function.

The focus of the role is on policy and strategy implementation and control rather than development and you will typically handle short-term operational/tactical responsibilities.

It will be a very big plus if you can bring experience in developing projects or sites from square one.

As the Manager of the Regulatory Affairs Sub-Function, you will be responsible to:

• 
  Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interact with regulatory agency to expedite approval of pending registration.
• Serve as regulatory liaison throughout product lifecycle.
• Participate in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serve as regulatory representative to marketing, research teams and regulatory agencies.
• Advise development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.

To be successful in this role, you will need to have the following

• Manufacturing operations and manufacturing change experience.
• People management experience.
• Experience resolving any issues regarding nonconformance.
• Strong attention to detail.
• Solid communication skills and ability to communicate at all levels.
• Experience with EU and US regulatory bodies.
• Strong organisational skills.

I am looking to speak with candidates that are degree qualified and have circa 3-5 years experience in a similar role within medical device, knowledge of EU & US Regulations is a must.

Reach out to Aisling at cpl recruitment, 087 4671309 or aisling.murray@cpl.ie