Regulatory Affairs Manager

You have a choice of where you want to work! We invite you along on our journey to Purify and Protect, with Every Fiber, for a Sustainable World!

Our company has tripled in size in the last five years. To support the growth in our transformation, the Ahlstrom Medical and Laboratory & Life Sciences Business Units are seeking a Regulatory Affairs Manager to have end-to-end responsibility for all related processes, performance management, communications, customer relations, and cooperation according to the functional model. We value, care, one team, growth mindset, and accountability in a diverse and global environment. Does this sound like an opportunity for you?

About the Job

In this role you will secure regulatory state-of-the-art processes across the entire product lifecycle, lead and support company-wide and mill-focused projects, and act as a strong business partner with a focus on leadership, regulatory and quality operations, proactively engaging in customer relations both internal and external.

Reporting to Head of Product Development, this role is responsible for ensuring that all regulatory processes and requirements are followed and for the preparation and implementation of the FDA regulations for Medical Devices and InVitro Diagnostics.

As the Regulatory Affairs Manager you will provide support to the Healthcare Manufacturing Sites and key project activities. You will apply advanced regulatory expertise in the FDA CF21.I area to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. These sites will act as the legal manufacturing sites and Authorized Representative sites. This role also acts as a backup for their counterpart in Europe for MDR/IVDR regulations support.

Essential Functions and Primary Responsibilities

• Knowledgeable and experienced on the FDA CFR21.I regulations and apply same to writing of technical files to be submitted to the FDA, and to other regulatory agencies. Able to support MDR / IVDR submissions as a backup for Europe.
• Develop and execute regulatory strategies to achieve products approvals.
• Direct complex decision making among global stakeholders and senior leaders in regulatory.
• Advise and guide regulatory strategy development and submission activities.
• Contribute to the development and functioning of the crisis/ issue management program.
• Ensure product safety issues and product-associated events are reported to regulatory agencies for supported geographies.
• Arrange, prepare for, and potentially leads meetings with the FDA, international agencies, or notified bodies.
• Monitor global regulatory changes and report impact.
• Manage processes involved with maintaining annual licenses and registrations.

Minimum Occupational Requirements

• Master’s / bachelor’s degree in a scientific discipline with a minimum of seven (7) years of experience in regulatory affairs in the USA
• Experience with 510(k) applications, EU MDR & IVDR submissions, technical file management or other international medical device regulations and submissions
• Demonstrated success in the GMP / Biotech / Pharma / Regulated Industry
• Excellent knowledge of Quality/Regulatory requirements in the IVD / Medical Device Industry including CFR21.I, MDR and IVD Regulations, ISO13485, ISO18385 and ISO9001 and other standards and regulations applicable to IVD / Medical Devices
• Exposure to a manufacturing environment
• Fluent English skills, written and spoken. Italian or French is a plus.
• Ability to travel.

Ahlstrom is an Equal Opportunity Employer. Equal opportunity is a sound and just concept to which we are firmly bound. Ahlstrom will not engage in discrimination against, or harassment of, any person employed or seeking employment with our company based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, non-disqualifying disability, status as a protected veteran or other characteristics protected by law.

About Us. Ahlstrom is a global leader in combining fibers into sustainable specialty materials. Our purpose is to Purify and Protect, with Every Fiber, for a Sustainable World. Our vision is to be the Preferred Sustainable Specialty Materials Company for all our stakeholders.

We serve five growing and distinctive end markets, which form the basis for our five divisions: Filtration, Food & Consumer Packaging, Healthcare, Building Materials, and Technical Materials.

Our pro forma net sales 2021 for continuing operations amounted to EUR 2.6 billion and we employ some 7,000 people.

Learn more at www.ahlstrom.com