Sr. Regulatory Affairs Associate

JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.)

ESSENTIAL DUTIES:

• Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, AU technical files, Japan, MEA and other countries as well as for human tissue bank products for US FDA and various States.
• Represent Regulatory Affairs on assigned project teams through all phases of product development, provide Regulatory Strategy and assess regulatory impact of changes on existing products
• Coordinate and prepare document packages for regulatory submissions to the US, EU, AU, and Canada (510(k) Pre-Market Notifications, Product Reports/Supplements, Tech Files, Health Canada)
• Responsible in the preparation and compilation of domestic and international product registration submissions.  This includes, but is not limited to Pre-Market Notifications, 510ks, AU technical files and international dossiers (Canada, Saudi Arabia, Japan, Egypt, Indonesia etc.), US Tissue Bank licenses, and Canada CTO licenses
• Represent Regulatory Affairs on change controls and provide regulatory assessment
• Review and approve marketing communication materials
• Provide guidance on global compliance, such as GMP and product registrations, clinical evaluations in accordance with US FDA, AU TGA, Canadian CMDCAS, MDSAP and ISO 13485,etc.
• Monitor regulatory and legislative environment and assess impact of new regulations and works with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes
• Provide information and materials for Certificate to Foreign Governments (CFG), and medical device listings for FDA
• Participate in the planning, conduct, and reporting for external audits (FDA, Notified Body,  international regulators, etc.) as requested
• Participate, as assigned, as a CAPA owner, team member, or “task” owner
• Work with project teams and responsible leaders to provide compliance/product registration requirements and potential effects for design changes and manufacturing process changes
• Direct communication with regulatory authorities regarding company’s regulatory filings
• Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends
• Create and update departmental standard operating procedures (SOPs)

MINIMUM REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIRED EDUCATION AND/OR EXPERIENCE:

• Bachelor's Degree (BA/BS) Life Sciences, or health care-related discipline required
• Minimum five (5) years of experience in Medical devices regulatory submissions required
• Experience with successful preparation and submission of 510(k) and international documents and registration and marketing of medical devices worldwide required.

 LANGUAGE SKILLS: Ability to clearly communicate and write reports and business correspondence in English.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism. 

OTHER PREFERRED EDUCATION, SKILLS and ABILITIES:

• Experience with FDA, Health Canada and international regulators is strongly preferred.
• Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.
• Ability to clearly communicate and write reports and business correspondence in English.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and other key members in the company while maintaining a high level of professionalism.
• Experience in supporting international registrations.
• Expert knowledge of US and international medical devices regulations, guidelines, and policies.
• Experience in design control process.
• Expert at compiling medical device documents into clear, easy-to-understand submissions packages.
• Expert at writing, reviewing, and editing technical documents.
• Highly effective at working with cross-functional teams from diverse disciplines and culture.
• Must be able to negotiate internally and externally with regulatory agencies.
• Identify, communicate, and solve regulatory issues with project reams and management.
• Strong organizational skills.
• Ability to read, understand and retain extensive working knowledge of procedures and company documents.
• Excellent MS-Office Applications. 
• Knowledge of computer files management software (SAP preferred)
• Able to produce positive results with a strong sense of urgency and ability to multi-task.
• Strong interpersonal and presentation skills.
• Knowledge of Quality System Requirements and Standards.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.