Regulatory Affairs Specialist II

16 Dec, 2020

Jobs

Regulatory Affairs Specialist II

Laborie Medical Technologies
Portsmouth, NH

Top Talent helps us to improve lives around the world.

Laborie Medical Technologies is currently searching for a Regulatory Affairs Specialist II to join our team in the Portsmouth, NH office.

Do you thrive in a changing environment? Do you enjoy a challenge and the excitement of being a change agent for a company?

Are you hungry? Hungry to share your ideas and the opportunity to learn and grow in a fast-paced environment?

Are you eager? Are you ready to dive in and showcase your fresh ideas and drive change? Will you roll up your sleeves, and help us find practical solutions?

Are you creative? Do you think outside of the box and love collaborating with cross-functional teams?

Do you like risk?  Do you take calculated risks to find creative solutions to problems?

Do you want to have some fun? While we are a company with a long history and large roots, we function like a start-up. If you have a passion for Quality, Perseverance, Accountability and Teamwork, and would like to help us improve lives around the world, come help us shape our future!

Who are we?

LABORIE is an industry-leading innovator, manufacturer and supplier of medical technologies and devices, with headquarters in the United States, Canada and the Netherlands. We enjoy a strong diversity of talent with 875 global employees. We have grown significantly over the past several years and continue to invest in new technologies, companies and regions.

Innovation

LABORIE takes great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. We are focused on educating healthcare providers and their patients on the latest solutions in Urological and Gastrointestinal health. But that’s not all…  recently we are delighted to announce that we have acquired Clinical Innovations, one of the largest healthcare manufacturers exclusively focused on labor, delivery and NICU.

Position Overview

The Regulatory Affairs Specialist II provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions. This individual performs regulatory submission/approval activities for specific complex Laborie Medical products.  Represents Laborie medical Regulatory with international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards. Ensures that product approvals are properly maintained and product re-registrations are properly managed. Exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.

Responsibilities

  • Define worldwide regulatory requirements necessary for regulatory approval of assigned products. Advise regulatory submission teams regarding such requirements and help coordinate implementation.
  • Complete worldwide regulatory assessments and strategies as required to support assigned projects and provide direction to project teams to support strategic new product development and product modifications as required.
  • Provide direction on application of external standards for assigned projects as required. Execute product submission strategies as directed.
  • Maintain all regulatory documentation to ensure availability for external audits and preparation of submission packages.
  • Review technical documentation, i.e. test reports, test protocols, etc., for completeness and compliance to regulatory standards.  Review includes using scientific judgement to guide the teams in understanding how to close any gaps that exist.
  • Rigorous documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, project schedules, approvals, renewals, and change orders.
  • Provide guidance and oversight to team members related to regulatory compliance.
  • Assist customers and distributors with updating and renewing product registrations as required.
  • Review company marketing literature for compliance to applicable regulations.
  • Maintain a thorough knowledge of current QSR and ISO requirements as they apply.

Qualifications

  • BS degree in Science or Engineering or equivalent job experience.
  • Minimum of 3-5 years’ experience in Regulatory Affairs preferred.
  • Minimum of two years medical device industry experience preferred.
  • Working knowledge with quality systems regulations and guidelines.
  • FDA, EU, Health Canada, TGA, PMDA, and international market submission experience preferred.
  • RAC Certification preferred.
  • Through understanding of international submission requirements including how to comply with standards and regulations.
  • Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
  • Working knowledge of medical devices, procedures and terminology preferred.
  • Proficiency with Microsoft Office.

LABORIE is committed to providing equal employment opportunity to all applicants and employees regardless of their race, creed, color, religion, sex, age, national origin, disability, military service, protected veteran status, genetic information, sexual orientation, gender identity, or any other characteristic protected by federal, state or local law. We are strongly committed to this policy and believe in the concept and spirit of the law.

LABORIE is further committed to ensuring that employment decisions are based on valid job requirements. In addition, all employment actions, such as recruiting, hiring, training, promotion, compensation, benefits, transfers, layoffs and termination are administered fairly to all persons on an equal opportunity basis, without discrimination on the basis of protected categories named above. LABORIE will also provide qualified applicants and employees with disabilities any needed reasonable accommodations, as required by law.

LABORIE will not tolerate employees and applicants to be subjected to harassment, intimidation, threats, coercion or retaliation because they engaged or may engage in filing a complaint or assisted in a review, investigation or hearing related to any federal, state or local law requiring equal employment opportunity; or because they opposed any act deemed unlawful.

LABORIE, (www.LABORIE.comis a leading global developer, manufacturer and marketer of medical technologies and devices.   We deliver innovative Urological and Gastrointestinal products that improve patients’ health and quality of life.  Our reputation and brand continues to be the “gold standard” in our industry. In business since 1967, LABORIE’s global reach extends to 11 offices, in 10 countries, with manufacturing facilities located in Canada, USA, The Netherlands and Switzerland. Working closely with clinicians, universities, and non-profits around the globe, we make a difference worldwide.

Today, LABORIE is one of the world’s fastest growing medical technology companies.  Since 2012, we have acquired 14 additional companies within our market space; product line offerings have increased, and we’ve expanded into new categories.  We are excited by our recent change in ownership to Patricia Industries, a division of Investor AB.  Investor AB is a leading owner of best in class international companies and holds significant shareholder interests in quality companies such as AstraZeneca, NASDAQ, ABB, Ericsson, Electrolux, Saab and many others.  With this new partnership, we continue to grow as we make acquisitions and further accelerate our growth strategies. This kind of growth signals an exciting time for the company and presents great opportunities for joining our team of action-oriented and forward-thinking individuals are inspired by challenging career opportunities.

Learn more here

Job posted: 2020-12-16