Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Date : Aug 5, 2024

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

Location : Lakewood, CO, US

Requisition ID : 32482

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells.

With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

Advancing healthcare with heart.

As a Senior Regulatory Affairs Specialist you play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products.

As a key contributor, you will develop strategic regulatory plans, expertly navigate submissions, and collaborate cross-functionally to address challenges and seize opportunities.

Your in-depth knowledge of global medical device and pharmaceutical regulations, exceptional communication skills, and proven track record in achieving successful submissions will make you an invaluable asset.

ESSENTIAL DUTIES

• Responsible for developing regulatory strategies and plans for new or modified product.
• Identifies and defines contents for regulatory submissions / dossiers. Influences the testing strategy and test report contents.

Supervise the assembly of the regulatory submissions.

• Write and prepare U.S. and international submissions for new products ensuring timely approval for market release.
• Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required, by geography.
• Maintain current and grow regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
• Represents regulatory on project teams to develop regulatory strategies, including reviewing the various specifications and testing plans / reports, keeping in mind defined target market.
• Review product labeling and ensure compliance with applicable US and international regulations.
• Negotiate and interact with and / or directs others in interacting with Regulatory Agencies and Certification authorities, during the development and review process to ensure submission approval.
• Identifies the need for, prepares, and conducts regulatory related training for the business.
• Reviews advertising and promotional materials for compliance with global regulations; analysis and recommends appropriate changes.
• Collaborates with individuals at different levels and develops or is responsible for the development of solutions to problems.
• Makes recommendations for improvements within the organization.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Participate in preparation and execution of audit required to enable of maintain market access.
• Identify the need for new or modified regulatory procedures, SOPs, and participates in development and implementation.
• Interprets the intent of regulations and policies and provides such information to project teams and management.
• Develops and executes strategies for responses to FDA, Notified Body, and government agency questions with team.
• Provide mentoring, training, and support to other members of the regulatory department.
• Assist in regulatory due diligence for potential and new acquisitions.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree in physical / biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Previous relevant experience and / or combined with a Masters in Regulatory Affairs may also be considered.

Experience

• Seven (7) years' experience in Regulatory Affairs preferred or a mix of Regulatory and Quality experience in a regulated environment.
• Previous relevant experience and / or combined with a Masters in Regulatory Affairs may also be considered.

Skills

• Must have excellent written and verbal communication skills.
• Must be self-motivated by working independently and having the ability to take ownership of her / his responsibilities.
• Must be able to prioritize and handle several projects concurrently.
• Must be able to provide leadership and mentoring skills and / or supervision to less experienced regulatory personnel.
• Must be able to maintain confidentiality in dealing with regulatory and clinical documentation.
• Must have authored a regulatory submission in the US, EU and / or Canada that was submitted for regulated agency review.
• Must have in-depth working knowledge of U.S. and / or international medical device and / or pharmaceuticals and / or biologics regulations and standards and the ability to apply knowledge to submissions reviewed by a regulated agency.
• Able to apply business insight and have ability to understand how product approval strategy interacts with business strategy.
• Demonstrated ability to collaborate and think innovatively (outside the box).
• Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.
• Apply previous regulatory experience to help ensure success of submissions.

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) preferred.

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

• Typical office environment requirements include : reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range : $95,900.00 to $119,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base : 10.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

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