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Regulatory Affairs Specialist
The Job Responsibilities
- Develops regulatory strategies by;
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Assessment of options and milestones to de-risk development programs and align with current regulatory requirements and agency guidance.
- Documenting path(s) to regulatory approval in the Regulatory Affairs Plan (RAP)
- Developing clear rationales for Letter-to-File (LTF) for product changes that will not impact product approvals or clearances.
- Responsible for:
- The procurement, assembly, and packaging of the required deliverables for the submission of product registration and approval information as appropriate.
- Preparation and submission of regulatory documentation according to applicable regulatory requirements and guidelines
- Communication and interaction with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
- Review labeling and marketing literature for compliance with regulatory requirements.
- Responsible for providing product support in preparing US and non-US product submissions:
- (510(k), Technical files, Canadian Licenses and International Registrations), by assessing the acceptability of quality, preclinical, and clinical documents in regulatory submissions to ensure compliance with applicable regulations.
- Provide support for domestic (federal, state, and local) and International products registrations, by:
- Researching existing documentation, preparing summary information, memos or statements (including CFG’s; certifications, apostille, and consularization).
- Partnering with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
- Assess global impact of changes to launched products and support notifications/submissions as required
- Supporting product life cycle management activities.
- Provide import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate.
- Review labeling and marketing literature for compliance with regulatory requirements
- Participates in the annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals.
- Maintain knowledge and application skills of regulations, standards and codes within job scope by doing the following:
- Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products
- Monitor and evaluate medical device regulation changes and develop and execute strategies for maintaining products on the global market.
- Helping train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Assist in the development and update of divisional regulatory procedures and SOPs to ensure regulatory compliance
- BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience.
- Minimum of 3-6 years of Regulatory experience in medical device industry is required. Minimum of 2 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities.
Special Competencies or Certifications:
- Regulatory Affairs Certification (RAC) a plus
- Knowledge of U.S. and International regulatory requirements for medical devices
- Proven record of supporting project teams
- Good Microsoft application skills
- Excellent written and oral communication skills
- Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820
Work Environment / Conditions:
- Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
- Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.
- Ability to travel nationally /internationally, up to 5-10% of the time
The Dräger Workplace
At Dräger, it is our passion and dedication to protect, support and save lives. Our dedication to life naturally extends to the quality of our employees’ lives. They are the essence of our company, and without them, we would not be what we are today – a world leader in medical and safety technology. We are searching for people who want to join us in building “Technology for Life”.
Who we are
Dräger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga.
Equal Opportunity Employer – Disability and Veteran
Dräger is responsible for life. The lives of our employees are especially important to us, therefore, Dräger provides a highly competitive and comprehensive benefits package. We invest boldly in a comprehensive benefits program – one that offers employees and their families a focus on wellness in addition to financial protection now and in the future.
What we offer
- Company sports and prevention courses
- Flexible working time
- Health center and gym
- Contributions to (occupational) pension plans
- Professional development opportunities and coaching
- Health Insurance
- Retirement savings
Please contact Tiffany Faulhefer at firstname.lastname@example.org for more information on how to apply.
Job posted: 2023-05-24