Sr. Regulatory Affairs compliance Manager (Project Management)

We are hiring for a Sr. Regulatory Affairs Compliance Manager.

The Senior Regulatory Affairs Compliance Manager is responsible for the domestic and international regulatory compliance for the Patient Safety medical devices and personal protection equipment designed and/or manufactured at TIDI Products, LLC and Enterprise compliance processes involving licensing and accreditation. Involvement begins as new products or product modifications initiate the design process to provide early guidance concerning regulatory requirements. This is a key leadership position and will be expected to model and deploy the TIDI corporate mission, core values, and guiding principles.

Essential responsibilities:
The position supports the Director of Regulatory Affairs in both domestic and international regulatory issues. The position is responsible for regulatory assessments and participates on project development teams to provide early guidance, review, and approval of regulatory strategy, labeling and promotional material for new and modified products manufactured under Posey Products branding, excluding any devices containing software. Coordinates the International Registration of TIDI Posey products.

This position is responsible for the domestic and international regulatory issues for the non-electronic medical devices designed and/or manufactured at TIDI in Tijuana Mexico under the Posey Brand as well as eyewear PPE. Involvement begins as new products or product modifications initiate the design process to provide early guidance concerning regulatory requirements, e.g., submissions, claims identification and substantiation, labeling, promotional materials and assuring the validity of clinical, ethical and regulatory compliance issues.

This position will have 2-3 direct reports, and be responsible for training and providing work direction and/or delegating aspects of the responsibilities below appropriate to the experience of the junior associate.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
This position is responsible to develop and implement procedures which ensure compliance to US and International regulations.
This position will oversee GUDID/EUDAMED and other applicable UDI database submissions through oversight of direct report regulatory specialist.
Conduct US and International regulatory assessments for new and modified products.
Frequent International registration submissions.
Develop and maintain EU technical files and/or design dossiers.
Participate on project development teams to provide early guidance, design control reviews, and Regulatory Strategy, including biocompatibility assessments or coordination of assessments with consultants (such as NAMSA).
Coordinate Certificates to Foreign Governments, Free Sales Certificates, Apostilles, and notarization.
Review and approve labeling for domestic and international compliance including meeting US, MDSAP and EU labeling requirements.
Approve all communications to trade publications, news media release, sales presentations and technical bulletins and analyze the support data for claims verification.
Maintain regulatory data, GUDID, and FDA establishment registrations and medical device listings as well as Health Canada Establishment Registration.
Works with Quality Compliance to initiate and execute field actions and is the Regulatory lead during any TIDI initiated field actions.
This position will be the lead regulatory contact for any import issues/inquiries with FDA and support the logistics team in clearing issues.
This position is responsible for state licensing, accreditation, establishment registrations/listings for all TIDI facilities and law label requirements for all TIDI products.
This position is responsible to develop and maintain a regulatory database for all TIDI products.
Evaluates and implements procedures pertaining to corporate and departmental regulatory compliance activities.
Accountable for modeling and providing training of the companys Mission, Vision, Values, Value Discipline and Behaviors
o Demonstrates and actively supports TIDI Products, LLC Mission, Vision, Values, Value Discipline and Behaviors;
o Collaborates effectively across the company and actions are consistent with Behavior Expectations.

CORE VALUES & GUIDING PRINCIPLES:
Understands internal and external customers
Assure a safe work environment
Encourage individual development Demonstrates teamwork and flexibility/adaptability
Demonstrates honesty
Keep our commitments
Think systemically and ensure constancy of purpose
Lead with humility and respect every individual
Focus on process, embrace scientific thinking, flow and pull value, assure quality at the source and seek perfection

Qualifications:
Thorough understanding of FDA and EU UDI requirements and applicable databases (GUDID/UDI).
Customs Export/Import knowledge.
Experience with Prescription Medical Devices and obtaining and maintaining state licensing
Understanding of International registration requirements.
ISO 13485, ISO 14971 & MDSAP.
Bachelor's or Master's degree preferably in Engineering, Physical Science, or a clinical field.
Minimum of 7 years experience in the following areas: Regulatory Affairs, Quality Management, or Engineering/Product Development with emphasis and knowledge on QSR (21 CRF 820) and ISO 13485:2016, EU MDR, and Canadian MDR requirements.
Management or team lead experience required.
Familiarity and experience with Design Controls is preferred.
RAPS Certification and/or ASQ certification in Auditing Biomedical is preferred.
Knowledge of FDA, EU MDR and MDSAP Regulations of medical devices and Personal Protection Equipment.
Knowledge of ISO 13485 and ISO 14971.
Ability to investigate and decipher US and International regulations.
Ability to make decisions, develop and execute regulatory strategy.
Ability to develop and implement compliant processes where none currently exists.
Ability to mentor and develop team members, including goal setting and performance reviews.
Ability to lead and direct the work of others ensuring maintenance of a robust Regulatory Affairs department.
Ability to manage multiple projects and teams.
Ability to identify and adapt to shifting priorities and competing demands
Ability to motivate individuals to collaborate on team projects and produce results
Excellent verbal and written communication skills

At TIDI Products we are committed to offering a comprehensive employee benefits program than help our employees stay healthy, feel secure and maintain a work/life balance.

About TIDI Products
TIDI Products is a market leading manufacturing of disposable infection prevention products and patient safety products, headquartered in Neenah, WI. We have manufacturing and distribution facilities in Neenah, WI, and, Tijuana, MX. TIDI provides best in class products and service to major healthcare products distributors and users worldwide.
We Support Care Givers and Protect Patients!!

Disability Accommodation
For individuals with disabilities that need additional assistance at any point in the application and interview process, please email WIHR@tidiproducts.com or call 920-751-4300.

Equal Opportunity Employer
TIDI Products is proud to be an equal opportunity employer and is committed to maintaining a diverse and inclusive work environment. All qualified applicants will receive considerations for employment without regard to race, color, religion, sex, age, disability, marital status, family.

Estimated starting annual base salary pay ranges is $145,000 - $160,000, less applicable withholdings and deductions, paid on a bi-weekly basis. Please note that the actual compensation offered may vary based on relevant factors as determined by the Company, which may include, but is not limited to, location, experience, qualifications, education, skillset, and market conditions. The target base compensation for this role is in the low to middle of the range, with the top of the range reserved for only exceptional circumstances. TIDI Products offers a competitive benefits package to eligible full-time employees, which currently includes medical, dental, and vision plans, 401(k) with employer matching contributions, life insurance, paid time off, tuition reimbursement, and more, as well as paid sick leave in accordance with applicable law. Each benefit is subject to eligibility requirements as specified in plan documents, and the Company reserves the right to modify the benefits it offers from time to time.