Job Title: Regulatory Affairs Specialist

Job Description

We are seeking a highly motivated Regulatory Affairs Specialist to join our team. The ideal candidate will be responsible for maintaining a comprehensive knowledge base of existing and emerging regulations for in vitro medical devices globally. You will collaborate effectively with project teams, peers, and customers to ensure regulatory strategies are met and support global product registrations.

ResponsibilitiesMaintain current knowledge base of existing and emerging regulations, standards, or guidance documents for in vitro medical devices globally (i.e. FDA, ISO, EU, IVDR, TGA, etc.).Collaborate effectively with project teams company-wide, peers, and customers to obtain and understand registration requirements and identify solutions regarding regulatory strategies.Coordinate, support, and author clear and concise regulatory filings for both domestic and international product registrations for in vitro diagnostic medical devices. Duties include writing, formatting, compiling, and maintaining supporting documentation/technical files for new products and product modifications.Communicate with regulatory agencies regarding potential regulatory pathways, compliance requirements, or clarification and follow-up of regulatory filings or submissions under review.Prepare technical information for specific customer/distributor or authorized representative requests to support global product registration (e.g., MDSAP for U.S., Australia, Canada, Brazil, and Japan).Participate in design control for products including review of design documentation, design changes, and update technical files as needed.Identify, obtain, and maintain relevant guidance documents, international standards, or consensus standards and complete gap analysis on new or updated regulations and standards to ascertain regulatory impact and recommend changes to ensure compliance.Perform Post Market Surveillance activities and review Post Market Surveillance data for regulatory compliance and reporting requirements.Investigate regulatory history of similar products as part of biannual Management Reviews.Collaborate effectively with project teams to identify risks and risk mitigation strategies.Write or update SOPs related to regulatory affairs responsibilities and actions.Essential SkillsBasic knowledge of US, ISO, and European regulations for in vitro diagnostics.Ability to work independently with minimum supervision.Good communication skills, both verbal and written.Effective project management and problem-solving skills.Good organizational ability and strong attention to detail.Proficiency in computer application packages, such as MS Word, Excel, and Adobe.Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time-essential constraints.Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.Strong work ethic and an ability to excel within a rapidly changing and growing organization.Additional Skills & QualificationsBachelor’s Degree in Biochemistry, Microbiology, or related field.1 or more years of previous related experience.Work Environment

The team structure includes about 10 people in regulatory and quality total. You will be working with other members across different offices as well as auditors and vendors. This is essentially a support role for the other Sr-level managers. The work environment is collaborative and fast-paced, providing opportunities to work under pressure and within deadlines.

Pay and Benefits

The pay range for this position is $35.00 - $65.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Franklin,MA.

Application Deadline

This position will be accepting applications until Jan 27, 2025.

About Actalent

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.

Diversity, Equity & Inclusion

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.